December 14, 2021: Webinar on Final Rule for Medical Device De Novo Classification Process, 1:00 p.m. ET 

December 14, 2021: FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site webinar, 1:00 p.m. ET

September 1-2, 2021: FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop (virtual), hosted by FDA’s Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in CDER and The University of Maryland CERSI

August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy public workshop, hosted by FDA CBER and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID)

August 25, 2021: Manufacturing, Supply Chain, and Inspections during the COVID-19 Public Health Emergency webinar, 9:00 a.m. - 1:00 p.m. ET, hosted by FDA's Center for Drug Evaluation and Research (CDER)

August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens 

July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA’s use of Emergency Use Authorizations (EUAs) and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.

July 13, 2021: Webinar on Revocation of EUAs for Non-NIOSH-Approved Respirators and Decontamination Systems, 12:00 - 1:00 p.m. ET - FDA will host a webinar to share information and answer questions about revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.

July 8, 2021: FDA Grand Rounds webcast - SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern, 12:00 - 1:00 p.m. ET - webcast recording

June 22, 2021: Sentinel Innovation and Methods Seminar series - Measure what you Treasure- the challenges and opportunities of collecting real world endpoints, 1:00 p.m. ET

June 22, 2021: FDA Drug Topics webinar: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers, 1:00 - 2:00 p.m. ET

June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

June 10, 2021: Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines - During this meeting, FDA will provide considerations on data to support licensure and Emergency Use Authorization for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss in open session, in general, the data needed to support an authorization and/or licensure of a COVID-19 vaccine intended for use in pediatric populations. The committee will not discuss any specific products. Meeting materials are now available.

June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register

June 8, 2021: Webinar on Transitioning from Use of Non-NIOSH-Approved Disposable Respirators, 12:00 - 1:00 p.m. ET - FDA will present information about the May 27, 2021, Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

June 1, 2021: FDA Drug Topics: Enhanced Drug Distribution Security: 2023 and Beyond, 1:00 - 2:15 p.m. ET - This webinar will provide updates on implementation of supply chain security requirements under the Drug Supply Chain Security Act and describe requirements that go into effect in 2023 for enhanced drug distribution security. Enhanced product tracing and verification will help protect patients by improving detection and response to suspect and illegitimate products and prevent the distribution of illegitimate products in the U.S.

May 26-27, 2021: 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD. View recordings and see 300+ posters - Also see: FDA in Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health, and the MCMi poster: Strengthening Regulatory Science to Further the Development of Medical Countermeasures

May 20, 2021: FDA Office of Women’s Health Webinar: COVID-19 Vaccines & Women, 2:30 - 3:30 p.m. ET - Join Dr. Kaveeta Vasisht, FDA’s Associate Commissioner for Women’s Health in a conversation with Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research to discuss COVID-19 vaccines and their use in women.

May 11, 2021: An Update from Federal Officials on Efforts to Combat COVID-19 - Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, MD, PhD testifies for FDA. - testimony

March 18, 2021: Senate Health, Education, Labor, and Pensions Committee Hearing: Examining Our COVID-19 Response: An Update from Federal Officials, including Peter Marks, M.D., Ph.D., Director, FDA Center for Biologics Evaluation & Research (CBER) - testimony

March 17, 2021: House Committee on Energy & Commerce, Oversight & Investigations Subcommittee Hearing: Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations, with witnesses including Peter Marks, M.D., Ph.D., Director, FDA CBER - testimony

March 11, 2021: FDA Grand Rounds webcast - Studies of SARS-CoV-2 NSP1 and Envelope Protein - 12:00 - 1:00 p.m. ET - Presented by Marli Azevedo, Ph.D., Research Biologist, NCTR -  To elucidate COVID-19 pathogenesis and develop a successful treatment will require a comprehensive understanding of all SARS-CoV-2 viral proteins. The aim of this study is to understand the role of NSP1 and envelope protein in disease pathogenesis. NSP1 and envelope protein were expressed in HEK293T cells. Please register in advance.

March 12, 2021: 365 Days and Counting: COVID-19's Impact on the Oncology Community Zoom webinar, 11:00 a.m. - 12:00 p.m. ET, hosted by the FDA Oncology Center of Excellence. Please register in advance.  

Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
FDA will host virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2. Check this link for future events in this series.

Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
FDA hosted webinars in 2020 to share information and answer your questions on respirators and other PPE. Printable slides and transcripts from previous events in this series are available. Check this link for future events in this series.

December 17, 2020: Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting (webcast) - to discuss the request for Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. Also see: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

December 16, 2020: Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA - webinar, 1:00 - 2:30 p.m. ET - Also see: Drug Trials Snapshots, including a new 2015-2019 Drug Trials Snapshots Summary Report (PDF, 1.5 MB)

December 12, 2020: Virtual press conference - First COVID-19 vaccine, live at 9:00 a.m. ET

December 10, 2020: Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting (webcast) - to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. Also see: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

December 4, 2020: SEND for CBER, What You Need to Know webinar, 1:00 - 2:00 p.m. ET, to discuss Center for Biologics Evaluation and Research’s (CBER’s) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. Please register in advance.

November 16, 2020: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs (virtual)

November 12, 2020: FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? (webcast) - 12:00 - 1:00 p.m. ET

November 6, 2020: Office of New Drug (OND) Research: Seeking Collaborators; Funding Opportunities Available - webinar, 1:00 - 2:30 p.m. ET - Includes an overview of OND’s Combatting Antibiotic-Resistant Bacteria (CARB) and 21st Century Cures Drug Development Tools Grant programs

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
April - October 2020: FDA hosted weekly virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET on Wednesdays. Check this link for future events in this series.

October 27, 2020: BARDA Industry Day 2020 (virtual)

October 22-23, 2020: FDA Public Workshop: Pediatric Dose Selection (virtual) - FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a two-day virtual public workshop to discuss the present state of dose selection and how it pertains to pediatric drug development. This workshop is intended for clinicians, drug developers, and regulators. Pre-registration is required.

October 22, 2020: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The Committee will meet to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. Meeting briefing document (PDF, 458 KB), and other event materials; live webcast begins at 10:00 a.m. ET

October 2, 2020: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 Southern Hemisphere influenza season, which is part of FDA’s year-round efforts to flight flu along with other public health partners like CDC and NIH.

September 28-30, 2020: Global Summit on Regulatory Science (virtual) - an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context (registration required)

September 17-18, 2020: Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines - virtual workshop - agenda (PDF, 176 KB)

September 17, 2020: Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities, a virtual symposium hosted by the HHS Office of Minority Health

September 15, 2020: PPE Webinar series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic, 12:00 - 1:00 p.m. ET

September 10, 2020: FDA Grand Rounds webcast: Advancing the Science of Real-World Data to Address the COVID-19 Pandemic, presented Amy P. Abernethy, MD, PhD, FDA Principal Deputy Commissioner and Acting Chief Information Officer, 12:00 - 1:00 p.m. ET, CE credit available

August 25-28, 2020: Regulatory Education for Industry (REdI) Annual Conference (webcast) - Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. CE credit available.

August 25-27, 2020: Preparedness Summit (virtual) - FDA's Elizabeth Sadove, JD, presented along with CDC speakers as part of the session "Federal Regulatory Updates on Use of Medical Countermeasures"

August 18, 2020: FDA webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). This event featured FDA's surgical masks umbrella EUA.

August 13, 2020: FDA Grand Rounds webcast - Nanotechnology: Over a Decade of Progress and Innovation at FDA, 12:00 - 1:00 p.m. ET - Also see the related report (PDF), issued July 2020

August 5, 2020: Developing Antifungal Drugs for the Treatment of Coccidioidomycosis (Valley Fever) Infection (virtual workshop).

August 4, 2020: Webinar series: Respirators for Health Care Personnel Use during COVID-19 Pandemic

August 4, 2020: Development Considerations of Antifungal Drugs to Address Unmet Medical Need (virtual workshop).

July 13-14, 2020: FDA and Duke-Margolis Public Meeting: Establishing a High-Quality Real-World Data Ecosystem, 1:00 - 4:30 p.m. ET (virtual)

July 7, 2020: Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic, 12:00 p.m. - 1:00 p.m. ET - FDA, along with the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host a webinar on the topic of Decontaminating Respirators for Health Care Personnel Use during the COVID-19 Pandemic. This webinar is the third in the respirator webinar series.

June 23, 2020: Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - FDA, along with the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host the second webinar in the webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic.

June 11, 2020: FDA Grand Rounds webcast - A Pandemic and a Call to Action for One Health: The FDA One Health Initiative - CE credit available

June 9-10, 2020: Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies webcast

June 9, 2020:  Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - FDA, along with speakers from Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will begin a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. During this webinar, the FDA will share information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help assure health care personnel on the front lines have the necessary supplies of respirators to meet the demand.

June 9, 2020: FDA Drug Topics: CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19 webinar, 1:00 - 2:00 p.m. ET This webinar will demonstrate CURE ID – a mobile app and web platform developed by FDA and NCATS/NIH, that gives the global clinical community the opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19. The webinar will also explain the features and goals of the platform.

May 15, 2020: Virtual Town Hall - 3D Printed Swabs, 1:00 - 2:00 p.m. ET - will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.  This is a collaboration between the FDA, the Department of Veterans Affairs’ (VA) Innovation Ecosystem, and the National Institutes of Health’s (NIH) 3D Print Exchange.

May 14, 2020: FDA Grand Rounds - Artificial Intelligence for Regulatory Science Research, presented by Weida Tong, PhD, Division Director, NCTR, 12:00 - 1:00 p.m. ET - CE credit available

May 11, 2020: Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, 2:00 - 3:00 p.m. ET - FDA will host a webinar for device manufacturers about the immediately in effect guidance issued on May 6, 2020.

April 30, 2020: SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency, 1:00 - 1:45 p.m. ET - Also see: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

POSTPONED April 20-24, 2020: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD) - This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities.

POSTPONED April 20-21, 2020: 12th annual Sentinel Initiative public workshop – Hosted by FDA, under cooperative agreement with the Robert J. Margolis, MD, Center for Health Policy at Duke University. This two-day, annual workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on the Sentinel system’s tools and data infrastructure, and promote engagement and collaboration with patients, industry and consumers.

March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology  (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of these advanced manufacturing technologies methodologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.

March 6, 2020: Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency, 1:00 - 2:00 p.m. ET - FDA will host a virtual Town Hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SAR-CoV-2. The purpose of the Town Hall is to help answer technical questions about development and validation of molecular tests for SARS-CoV-2 and the recently-issued guidance.

March 5, 2020: Advancing Animal Models for Antibacterial Drug Development (Silver Spring, MD and webcast) - Hosted by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to discuss progress and challenges in the development and advancement of various animal models for serious infection.

March 5, 2020: Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine (Silver Spring, MD and webcast) - To discuss evaluation techniques for hardware, standards development, and assessment challenges for applications of Extended Reality (XR) in medicine. The goal is to identify critical gaps that may impede medical XR device development, innovation, and to advance the evaluation of medical XR devices and applications, thus accelerating the development of safe and effective medical XR devices benefiting patients and healthcare.

March 4, 2020: Vaccines and Related Biological Products Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season.

March 3-5, 2020: Mitigating the Impact of Blast-related Burn Injuries: From Prolonged Field Care to Rehabilitation and Resilience (Arlington, VA), hosted by the DoD Blast Injury Research Coordinating Office, U.S. Army Medical Research and Development Command, on behalf of the DoD Executive Agent for Medical Research for Prevention, Mitigation, and Treatment of Blast Injuries.

March 3, 2020: Public workshop - Facilitating End-to-End Development of Individualized Therapeutics (Silver Spring, MD and webcast) - To foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness.

March 2, 2020: Webinar: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests, 3:00 - 4:00 p.m. ET - FDA will host a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance. Also see: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency

February 25-26, 2020: Public workshop - Evolving Role of Artificial Intelligence in Radiological Imaging (Bethesda, MD and webcast) - Through this workshop, FDA is seeking to engage with stakeholders to explore benefits and risks of evolving applications of artificial intelligence (AI) in radiology.

February 25-26, 2020: Developing Medical Countermeasures To Treat the Acute and Chronic Effects of Ocular Chemical Toxicity (Rockville, MD) - Development of MCMs that mitigate acute and chronic corneal manifestations in response to ocular toxicants relies on the development of well-characterized experimental models with defined pathophysiology that allow for effective bridging to humans. Such models are also essential to demonstrate therapeutic efficacy. This meeting, sponsored by the NIH Chemical Countermeasures Research Program (CCRP), will bring together subject matter experts from the civilian and military research communities to discuss the current state of the field, including potential therapeutic approaches and available models.

February 13-14, 2020: FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020 (London, UK) - Day one will be available through a livestream.

February 13, 2020: FDA Grand Rounds: Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays webcast, 12:00 - 1:00 p.m. ET

February 3, 2020: Advancing EUA IVD Products Toward Full Marketing Status workshop (Silver Spring, MD) - Hosted by FDA and the Medical Device Innovation Consortium (MDIC), this workshop will explore key considerations for using real world data (RWD) to generate real world evidence (RWE) to help support in vitro diagnostic (IVD) products available under FDA’s Emergency Use Authorization (EUA) to advance to full marketing status.

January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) - The Working Group will 1) hear presentations from the eight subcommittees on their findings and potential actions for the TBDWG to consider; 2) hear updates from the Public Comment and Inventory Subcommittees; and 3) further discuss plans for developing the 2020 report to the HHS Secretary and Congress on federal tick-borne activities and research.

January 28-30, 2020: ASM Biothreats (Arlington, VA) - Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee)  

December 5-6, 2019: Repurposing Off-Patent Drugs: Research & Regulatory Challenges (Rockville, MD) - Hosted by FDA, the U.S. National Institutes of Health (NIH), and the Reagan-Udall Foundation for the FDA, this workshop will explore opportunities and challenges in assessing the safety and efficacy of repurposed drugs; patient experiences; and potential strategies to prioritize certain drugs and diseases for repurposing.

December 4, 2019: Informational Meeting: The Importation of Infectious Biological Agents, Infectious Substances and Vectors (webcast), hosted by CDC - This webcast is an opportunity for all interested parties (e.g., academic institutions; biomedical centers; commercial manufacturing facilities; federal, state, and local laboratories, including clinical and diagnostic laboratories; research facilities; exhibition facilities; and educational facilities) to obtain specific guidance and information regarding import permit regulations for the importation of infectious biological agents, infectious substances and vectors. The webcast will also provide assistance to those interested in applying for an import permit from federal agencies within the United States. Register by November 22, 2019. Also see Import Permit Program (IPP), from CDC

December 3, 2019: HHS National Biodefense Science Board: Public Meeting (Washington, DC and webcast) - To gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.

November 22, 2019: Blood Products Advisory Committee meeting (Silver Spring, MD and webcast) - The committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.

November 19, 2019: FDA Drug Topics webinar - Drug Shortages: FDA Efforts, Current Challenges and Future Goals, 1:00 - 2:00 p.m. ET - This webinar will introduce the FDA's Drug shortage program, explain how the agency is addressing drug shortages and speak to the various challenges that lead to drug shortages.

November 18-21, 2019: Chemical and Biological Defense Science & Technology (CBD S&T) Conference  (Cincinnati, OH) Hosted by the Defense Threat Reduction Agency (DTRA). FDA's CDR Todd Myers will be presenting as part of a panel on Alternate and Innovative Mechanisms to Conduct Medical Countermeasure Discovery and Development with the Federal Government.

November 18-19, 2019: Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development (Silver Spring, MD and webcast) - Co-sponsored by FDA, the Infectious Diseases Society of America (IDSA), the National Institute of Allergy and Infectious Diseases (NIAID), and Pew, this workshop will bring together a diverse array of subject matter experts in the fields of infectious diseases (ID), academics and industry and other government bodies to better understand the current state of U.S. based ID trials and how to enhance enrollment and research in such trials.

November 18, 2019: Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop (Silver Spring, MD and webcast) - To discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions.

November 12-14, 2019: Regulatory Education for Industry (REdI): Clinical Investigator Training Course (College Park, MD) This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products.

November 8, 2019: Vaccines and Related Biological Products Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss and make recommendations on the development of chikungunya vaccines.

October 27-30, 2019: 56th Interagency Botulism Research Coordinating Committee (IBRCC) meeting (Ellicott City, MD), hosted by the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) - IBRCC's mission is to provide a mechanism for coordination between federal and non-federal agencies to improve public health responses to, and medical countermeasures against, botulism in all its forms.

October 16-17, 2019: Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium (College Park, MD and webcast) - Hosted by CDER Small Business and Industry Assistance (SBIA), FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.

October 16, 2019: Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions – Final Guidance, 12:00 - 1:30 p.m. ET

October 16, 2019: Antimicrobial Drugs Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.

October 15-18, 2019: 9th World Meliodosis Congress (Hanoi, Vietnam) - Held once every three years to bring together the international melioidosis research community, co-organized by the Institute of Microbiology and Biotechnology, Vietnam National University, Hanoi and the Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Austria.

October 15-16, 2019: BARDA Industry Day - Limited onsite registration will be available beginning at 7:30 a.m. on October 15. As an alternative, consider registering for an Accelerator Network hybrid video streaming event on October 15. #BARDA2019

October 9, 2019: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and webcast) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season.

October 3, 2019: Developing Real-World Data and Evidence to Support Regulatory Decision-Making (Washington, DC) - Through extensive engagement with the stakeholder community, FDA published a framework (PDF) for the Agency’s RWE Program in December 2018. This conference will bring together leading experts to discuss questions about and topics addressed in the framework, as well as emerging topics in the development of real-world data and evidence.

September 25-26, 2019: 2019 Complex Generic Drug Product Development Workshop (College Park, MD and webcast) - FDA will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science, hosted by CDER Small Business & Industry Assistance.

September 24-26, 2019: 9th Global Summit on Regulatory Science (Lake Maggiore, Italy) An international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context. This year's theme is Nanotechnologies and Nanoplastics.

September 18-19, 2019: Workshop on Standards for NGS Detection of Viral Adventitious Agents in Biologics and Biomanufacturing (Gaithersburg, MD) - This National Institute of Standards and Technology (NIST) workshop, co-organized with FDA, will focus on the development of different types of standards for supporting standardization of Next Generation Sequencing (NGS) for detection of adventitious viruses in biologics (including viral vaccines, gene therapies, and biotherapeutics).

September 18, 2019: Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA Activities public workshop (Silver Spring, MD and webcast)

September 16-17, 2019: Identification and Use of Biomarkers to Advance Development of Preventive Vaccines Public Workshop (Rockville, MD and webcast) - Hosted by the FDA Center for Biologics Evaluation and Research, the National Institutes of Health, and the Coalition for Epidemic Preparedness Innovations, the purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications. Agenda (PDF, 87 KB)

September 12, 2019: HHS Tick-Borne Disease Working Group (online) - The Working Group will receive reports from the eight subcommittees that were formed during the June 4, 2019, meeting and continue to focus on plans to develop the next report to the HHS Secretary and Congress on federal tick-borne activities and research.

September 11-12, 2019: 2019 FDA Science Forum (Silver Spring, MD and webcast) - Topic areas include: Outbreak! FDA’s approach to prevention and response, including prevention through cybersecurity and promoting medical product and food security, and rapid response to infectious disease and foodborne pathogen outbreaks, e.g. the use of the Animal Rule, emergency communication devices, rapid diagnostic tests, antimicrobial resistance. Also see: FDA in Brief: FDA’s 2019 Science Forum highlights latest regulatory science in emerging technologies and leading public health challenges

September 11, 2019: The HHS Office of the Secretary is hosting a National Biodefense Science Board (NBSB) Public Meeting (Washington, DC) to gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.

September 9-10, 2019: 7th Annual FDA Scientific Computing Days (Silver Spring, MD) - This year’s event theme is Scientific Computing and Health Data Flows: The Heart and Lifeblood of Public Health Innovation.

August 19-22, 2019: Military Health System Research Symposium (Kissimmee, FL) - Hosted by the Department of Defense (DoD), this symposium provides a venue for presenting new scientific knowledge resulting from military-unique medical research and development. FDA will provide regulatory updates, and FDA and DoD representatives will discuss FDA/DoD collaborations, regulatory communications, and product development in an interactive panel discussion.

August 13, 2019: Webinar - FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions, 3:00 - 4:30 p.m. ET - FDA will host a webinar on two FDA Innovation Challenges to spur the development of new approaches to device sterilization. FDA’s Center for Devices and Radiological Health will accept applications for this challenge through October 15, 2019. Also see: Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing

July 23, 2019: The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will host a Project Call 3.1 Concept Phase Webinar at 2:30 p.m. ET. Project Call 3.1 seeks proposals addressing technology, workforce development, and global health priority areas identified by NIIMBL members.

July 17, 2019: Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations public workshop (Washington, DC and webcast) - To capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring. Also see draft guidance A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers, issued in March 2019.

July 16, 2019: Public Meeting: Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs (Rockville, MD and webcast) - The FDA’s Center for Veterinary Medicine will conduct a public meeting to gather input about alternative approaches in clinical investigations for new animal drugs, including incorporating complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs.

July 12, 2019: Public meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs (Silver Spring, MD and webcast). The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, Limited Population Pathway for Antibacterial and Antifungal Drugs that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. Submit comments by August 12, 2019.

July 11-12, 2019: Leveraging Randomized  Clinical  Trials  to Generate Real-World  Evidence for Regulatory Purposes public workshop (Washington, DC and webcast) - To explore key considerations for utilizing randomized designs, such as large simple trials or those that incorporate pragmatic elements, and real-world data (RWD) to generate real-world evidence (RWE). Discussion will focus on key components of trial design including intervention selection, outcome measurement, blinding, and study population characteristics as well as important regulatory considerations.

June 26-28, 2019: NIIMBL National Meeting (Washington, DC) - The program will feature perspectives from industry and government leaders and showcase the work of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) community as it develops the cutting-edge technologies and training programs designed to enhance patient access to life-saving medicines. FDA's Dr. Peter Marks (CBER), Dr. Janet Woodcock (CDER), and Principal Deputy Commissioner Dr. Amy Abernethy are among the featured speakers. (fee)

June 26, 2019: Strategic National Stockpile (SNS) Temperature Considerations for Medical Countermeasures Webinar, 1:30 p.m. ET, hosted by CDC - The purpose of this webinar is to provide public health partners with an overview of the Strategic National Stockpile’s responsibilities for maintaining and distributing cold chain products. It will also explain what the state planning considerations should be for receiving and transporting medical countermeasures (MCM) from the stockpile to local vaccination points. Free CDC TRAIN account required to register.

June 18, 2019: FDA Drug Topics webinar: Introduction to the Office of Orphan Products Development (OOPD), 1:00 p.m. ET - This webinar will discuss the history of the Office of Orphan Products Development, the orphan drug act, and OOPD's core programs.

June 10, 2019: Regulatory Education for Industry (REdI) Webinar: Financial Incentives for CDER Medical Products, 10:00 a.m. - 3:00 p.m. ET - Among other topics, this webinar will cover the logistics of priority review vouchers (PRVs). Specifically, they will provide general information on three FDA priority review voucher programs and specific information on how to redeem a voucher, what information to submit, and when to pay. Please register in advance. Also see: MCM priority review voucher program

June 6, 2019: Antimicrobial Drugs Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB).

June 4, 2019: Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) - Working Group members will focus on plans to develop the next report to the HHS Secretary and Congress on federal tick-borne activities and research.

May 29-30, 2019: Regulatory Education for Industry (REdI) Annual Conference (Boston, MA and webcast) - This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements, hosted by CDER Small Business & Industry Assistance.

May 21, 2019: FDA Drug Topics webinar: 3D Printing in Drug Development and Emerging Health Care, 1:00 - 2:00 p.m. ET - This webinar will discuss the emerging paradigm shift in drug manufacturing by three-dimensional (or 3D) printing. It will also focus on CDER’s use of emerging technology with respect to clinical medicine, and the pharmaceutical and regulatory sciences, as it relates to drug development and review. CE credit available.

May 20-22, 2019: Filovirus Animal Non-clinical Group (FANG) Workshop (Rockville, MD and webcast) - To update the FANG (an interagency working group) and other members of the filovirus community on cross-cutting topics that impact vaccine and therapeutic product development and regulatory approval.

May 14, 2019: Public workshop: BioCompute Objects: Tools for Communicating NGS Data and Analysis (Silver Spring, MD and webcast), co-sponsored by FDA, the George Washington University and the BioCompute Partnership to engage more stakeholders in creating and using BioCompute for NGS and other bioinformatics data analysis communications with the FDA. Specifically, the workshop will have two components: use case examples, and hands on & demonstrations of new tools that leverage BioCompute. A new Precision FDA-BioCompute Challenge will also be launched at the event.

May 9, 2019: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies - CDER SBIA webinar, 10:00 a.m. - 3:00 p.m. ET -  FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries. This event will demonstrate the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers will receive an orientation to the GitHub repository and will learn helpful tips for setting up and configuring the system for study managers and participants.

May 9, 2019: FDA Grand Rounds webinar - Gaining Insight into the Patient’s Experience by Harnessing the Power of Social Listening and FDA Archival Data, 12:00 - 1:00 p.m. ET, presented by Christine Lee, PharmD, PhD, FDA Center for Drug Evaluation and Research

May 2, 2019: Reagan-Udall Foundation annual public meeting (Washington, DC)  - The Foundation will discuss its activities and how they support FDA. (Federal Register notice)

May 1, 2019: FY 2019 Generic Drug Regulatory Science Initiatives public workshop (Silver Spring, MD and webcast) - To provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives.  To attend in-person or via webcast, register by April 1, 2019 by emailing complete contact information for each attendee (including the attendee's name, title, affiliation, address, email, and telephone number) to [email protected]. Also submit any requests to make oral presentations as part of your registration email. Submit comments by June 1, 2019.

April 29, 2019: Health Canada and U.S. FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH) (Silver Spring, MD and webcast) - The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Amsterdam, Netherlands, scheduled for June 1 - 6, 2019.

April 25-26, 2019: Disasters and Health: State of Science (Washington, DC), hosted by the National Center for Disaster Medicine and Public Health, Uniformed Services University - The objective of the symposium is to identify the important issues enabling and constraining an evidence-based approach to disaster preparedness and response, with a particular focus on health.

April 18, 2019: NIIMBL Global Health Fund Workshop: Replacing Animal-based Release Testing for Vaccines (Washington, DC area) - This workshop will explore the current state of animal-based release testing and discuss alternative approaches. Organizers encourage those with in-depth knowledge of in vitro vaccine potency and toxicity tests to consider attending.

April 17, 2019: Biodefense Summit: Implementation of the National Biodefense Strategy (Washington, DC and webcast) - Aims to engage the biodefense stakeholder community to inform national biodefense enterprise efforts to counter biological threats, reduce risk, prevent, prepare for, respond to, and recover from biological incidents. Sponsored by Federal departments and agencies with responsibilities or capabilities pertaining to biodefense, the Summit will inform implementation of the National Biodefense Strategy.

April 17, 2019: Public Meeting on the Draft Guidance to Support Compliance with the Intentional Adulteration Rule (College Park, MD and webcast) - To discuss the draft guidance for compliance and implementation of the “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule (Intentional Adulteration rule), which was issued under the FDA Food Safety Modernization Act.

April 16 - 18, 2019: 2019 Vector Summit (Pittsburgh, PA), hosted by NACCHO - to increase the capacity of local mosquito and tick management professionals to detect, prevent, prepare for, and respond to vector-borne disease (free)

April 11, 2019: FDA Grand Rounds webcast: Uncertainty is the only certainty there is: Potential approaches for making public health decisions, 12:00 - 1:00 p.m. ET, presented by Richard A. Forshee, PhD, Associate Director for Research, Office of Biostatistics and Epidemiology, FDA's Center for Biologics Evaluation and Research - Please register in advance.

April 9-11, 2019: 4th FDA/PQRI Conference on Advancing Product Quality (Rockville, MD) - Hosted by FDA and the Product Quality Research Institute (PQRI), the conference brings together regulatory, industry and academic leaders to discuss critical topics in drug product delivery design, development, and manufacture. (fee)

April 8-12, 2019: Achieving Data Quality and Integrity in Maximum Containment Laboratories Course (Bethesda, MD), hosted by MCMi and the UTMB - This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities. Registration closed on March 7, 2019; waitlist for next year available. (free, but space is limited)  More about this course

April 8-10, 2019: Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens (Bethesda, MD), hosted by FDA's Medical Countermeasures Initiative (MCMi) and the University of Texas Medical Branch at Galveston (UTMB)  - New course focusing on the preparation and execution of research clinical trials to facilitate the approval of medical countermeasures for high-consequence pathogens. Registration closed on March 7, 2019; waitlist for next year available. More about this course

April 8, 2019: Public workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Infection (Silver Spring, MD and webcast) - to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease.

April 8, 2019: Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (teleconference), 12:00 - 2:00 p.m.

April 3-5, 2019: Eleventh Annual Sentinel Initiative Public Workshop (Bethesda, MD) - Experts will share recent developments within the Sentinel Initiative, provide training on Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry and consumers. Also see the Sentinel System Five-Year Strategy: 2019-2023 (PDF, 1.7 MB)

March 26-29, 2019: Preparedness Summit (St. Louis, MO) - This year’s theme is “Preparedness Summit 2019: The Evolving Threat Environment.

March 26, 2019: FDA Drug Topics: An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (CDER) - CE webinar, 1:00 - 2:00 p.m. ET

March 22, 2019: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD) - In follow-up to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines, the Center for Biologics Evaluation and Research will reconvene the VRBPAC to discuss and make recommendations specifically on the H3N2 strain. The VRBPAC previously met on March 6, 2019, and made recommendations on the selection of all other strains to be included in seasonal influenza virus vaccines for the 2019-2020 influenza season.

March 20-21, 2019: Blood Products Advisory Committee meeting (Silver Spring, MD and webcast) - Matters considered at the meeting will include testing of the blood supply for Zika virus. (Federal Register notice)

March 19, 2019: Webinar - Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices, 3:00 - 4:30 p.m. ET

March 18, 2019: Enhancing the Incorporation of Patient Perspectives in Clinical Trials public workshop (Silver Spring, MD and webcast) - The workshop, convened by the Clinical Trials Transformation Initiative (CTTI), will discuss stakeholders' perspectives on challenges and barriers to patients participating in clinical trials and best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up.

March 6-7, 2019: Joint Civil & DoD CBRN Symposium (Alexandria, VA) - To provide a forum for CBRN stakeholders to discuss the latest updates in advancing a government-wide approach to improving CBRN defense, readiness and response strategies and capabilities. (fee)

March 6-7, 2019: Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting (Silver Spring, MD and webcast) - Topics include discussion and recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season.

March 5-6, 2019: Vaccine strategies for endemic fungal pathogens (Rockville, MD), hosted by NIAID

March 5, 2019: CDISC SENDIG-AR public webinar, 11:00 a.m. – 12:30 p.m. ET - Free webinar providing an overview of the draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR), hosted by the Clinical Data Interchange Standards Consortium (CDISC). See Electronic data standards for Animal Rule studies for more information

February 28 - March 1, 2019: Disaster Research Response (DR2) Tucson Workshop (Tucson, AZ), hosted by partners including the National Institute of Environmental Health Sciences (NIH), and the University of Arizona College of Medicine - Tucson. FDA representatives plan to attend. Registration will close February 15, 2019, or when capacity is reached. Poster abstracts will be accepted until February 6, 2019.

February 12, 2019: Webinar - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, 3:00 - 4:30 p.m. ET

January 30-31, 2019: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria public meeting (Washington, DC and webcast) - Register by January 23, 2019. This meeting will be dedicated to hosting stakeholders to explore priority areas that have emerged since the original National Action Plan for Combatting Antibiotic-Resistant Bacteria (PDF, 519 KB)  was launched in 2015. (Federal Register notice) Note: The Advisory Council is also seeking information from the general public and stakeholders related to efforts and strategies to combat antibiotic resistance.

January 29-31, 2019: ASM Biothreats (Arlington, VA), hosted by the American Society for Microbiology (fee)

January 24, 2019: NICBR Winter Symposium: Novel Therapeutics (Frederick, MD), hosted by the National Interagency Confederation for Biological Research - This symposium will feature talks from the Frederick research community on novel therapeutics for infectious diseases, cancer and autoimmunity.

January 17, 2019: Webinar - Breakthrough Devices Program Final Guidance, 1:00 - 2:30 p.m. ET - To help clarify the Breakthrough Devices Program final guidance for manufacturers.

January 9, 2019: Webinar for industry - CLIA Waiver Applications Draft Guidances, 1:00 - 2:30 p.m. ET - To discuss and answer questions about two draft guidance documents intended to help manufacturers of in vitro diagnostic (IVD) devices apply for and receive Clinical Laboratory Improvement Amendments (CLIA) waivers.

January 5, 2019: Innovations in Regulatory Science Summit (San Francisco, CA), hosted by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) - A gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development. Keynotes will be given by Dr. Janet Woodcock and Dr. Peter Marks, from FDA. (fee)