MCMi Events Archive
Archived medical countermeasure-related events, conferences, and workshops from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), other FDA centers/offices, and government and industry partners. Also see our news archive.
This page is an archive of previous events. Presentations and meeting files linked from this archive page may not contain the latest available information.
2022 | 2021 | 2020 and earlier
2022 events
-
December 8, 2022: FDA Grand Rounds: Wastewater Surveillance for SARS-CoV-2 Variants: a pandemic response project leveraging FDA’s GenomeTrakr network (virtual, 12:00 - 1:00 p.m. ET) - With funding from the American Rescue Plan Act, FDA scientists leveraged an existing laboratory network normally tasked for foodborne pathogen surveillance to start sequencing SARS-CoV-2 from regional wastewater treatment plants across the US. New laboratory and analysis methods, public database structures, and FDA dashboard summarizing data collected were developed for this project.
-
December 8, 2022: Blood Products Advisory Committee meeting (virtual) - The committee will meet in open session to hear an overview of the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
-
December 7-8, 2022: The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 (virtual public workshop) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation.
-
December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
-
December 6, 2022: FDA Broad Agency Announcement Day - FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2023 BAA, and how to apply. A recording will be posted after the event.
-
November 17, 2022: FDA Grand Rounds - Medical Extended Reality: Applications and Challenges (webcast, 12:00 - 1:00 p.m. ET) - FDA Physicist and Office of Science and Engineering Laboratories (OSEL) Medical Extended Reality (MXR) Program Coordinator Ryan Beams, Ph.D., will present an overview of augmented and virtual reality technology and of the landscape of potential medical applications. He will also discuss regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine
-
November 15-16, 2022: BARDA Industry Day - Save the date! The Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), invites you to participate in its annual conference to learn about U.S. Government medical countermeasure priorities, interact with the BARDA and ASPR teams, and network with public and private sector colleagues.
-
November 15-16, 2022: 14th Annual Sentinel Initiative Public Workshop (virtual) - Hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, participants will hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic and monkeypox public health emergency.
-
November 15, 2022: Virtual Public Workshop - CDRH Industry Basics: Understanding Risk with Medical Devices (1:00 - 3:00 p.m. ET) - The workshop will expand on the basics of risk with medical device use by featuring Risk Basics for Medical Devices and Application of Risk Management Principles for Medical Devices. Participants may choose one or both sessions. No registration required.
-
November 14-16, 2022: FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement (virtual) - To facilitate interaction among distributed manufacturing (DM)/ point of care (POC) stakeholders on critical areas for development and implementation of DM and POC technologies including terminology, technical challenges to adoption, operation of Pharmaceutical Quality Systems, good manufacturing practice expectations, and the unique challenges and considerations that apply to complex biologics.
-
November 9, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee (virtual, 9:00 a.m. - 5:00 p.m. ET) - The committee will discuss the request for EUA 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
-
November 8, 2022: Maximizing Benefits and Minimizing Harms from Antibiotics: Scientific, Regulatory and Clinical Considerations by Dr. Sara Cosgrove (webcast, 3:00 - 4:00 p.m. ET), hosted by the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation (CERSI). This presentation will address approaches to optimize antibiotic use through antibiotic stewardship including updates regarding federal regulations, strategies to enhance antibiotic stewardship and minimize antibiotic-associated adverse events throughout all healthcare settings, and approaches to change attitudes and behavior around antibiotic prescribing. Please register in advance.
-
October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
-
October 13, 2022: FDA Grand Rounds - Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins (webcast, 12:00 - 1:00 p.m. ET) - MAM is a liquid chromatography-mass spectrometry based peptide mapping approach used for the identification and quantitation of product quality attributes in therapeutic proteins.
-
October 13, 2022: CDC webinar: Melioidosis in the United States: What Clinicians Need to Know Following Newly Discovered Endemicity (2:00 - 3:00 p.m. ET) - The causative bacteria Burkholderia pseudomallei was recently found in soil and water in the southern United States. This bacterium causes a rare and serious disease called melioidosis. During this COCA Call, presenters will provide updates on the new and evolving epidemiology of melioidosis in the U.S. and discuss what clinicians need to know to prevent, diagnose, and treat melioidosis.
-
October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
-
October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
-
October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 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.
-
September 28, 2022 (series): Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) - Topics will cover both SARS-CoV-2 (COVID-19) and monkeypox. No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. The future town hall events scheduled for October 5 and 12, 2022 will be on the topic of monkeypox only.
-
September 27, 2022: FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines (webinar, 1:00 - 2:15 p.m. ET) - To provide an overview of the development and federal regulations for vaccines in the United States, including key statutes that grant FDA authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval.
-
September 22, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - The committee will meet in open session to discuss the Biologics License Application # 125739 (BLA - 125739) from Rebiotix Inc. for a product, Rebyota (Fecal Microbiota, Live), with a requested indication to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
-
September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost. The NARMS public meeting will be held virtually on Wednesday, September 21, 2022 from 12:00 p.m. to 5:00 p.m. ET and Thursday, September 22, 2022 from 9:30 a.m. to 4:30 p.m. ET. A virtual technical workshop to demonstrate how to access NARMS data online will be held on Tuesday September 20, 2022 from 9:00 a.m. to 4:00 p.m. ET.
-
September 21, 2022: Virtual Town Hall Series – Monkeypox Test Development and Validation (12:05 - 1:00 p.m. ET) - Starting September 21, 2022, FDA will host regular virtual town halls for monkeypox test developers. During the virtual town halls, the FDA will share information and answer questions from attendees.
-
September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. Advance registration required.
-
September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
-
September 14, 2022: U.S. Senate Committee on Health, Education, Labor & Pensions hearing: Stopping the Spread of Monkeypox: Examining the Federal Response (10:00 a.m. ET) - FDA Commissioner Dr. Robert Califf will testify. (Written testimony)
-
September 14, 2022: Webinar on the Policy for Monkeypox Tests (12:05 p.m. - 1:00 p.m. ET) - FDA will host a webinar about the recently published final guidance, Policy for Monkeypox Tests to Address the Public Health Emergency. During this webinar the FDA will provide highlights of the final guidance and answer questions from webinar attendees.
-
September 14, 2022: An Overview of Sentinel’s Publicly Available Analytics Tools webinar (12:00 p.m. ET) - This webinar will explore the resources available in Sentinel for individuals unfamiliar with Sentinel’s analytics tools and the Sentinel Common Data Model. Please register in advance.
- September 12-13, 2022: DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop (virtual, 5:30 - 9:30 a.m. EDT) - Embracing The Future: Regulatory Considerations And Industry Perspectives On Advanced Manufacturing - FDA's India Office and the Drug Information Association (DIA) India Office will host a two-day workshop on regulatory policies, guidance and support for the adoption of advanced manufacturing technologies.
- September 8, 2022: FDA Grand Rounds: Polio Vaccines: Past, Present and the Future (webcast, 12:00 - 1:00 p.m. ET) - To discuss the evolution of vaccines against poliomyelitis driven by the change in disease epidemiology, socio-economic circumstances, and advances in biotechnology.
-
September 1, 2022: The First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness Plan webinar (1:30 - 3:00 p.m. ET) - The White House Office of Science and Technology Policy (OSTP) is hosting a webinar on the occasion of the release of the American Pandemic Preparedness Plan Annual Report. Also see the initial report (Sept. 2021), from the White House: American Pandemic Preparedness: Transforming Our Capabilities (PDF, 598 KB)
-
August 30, 2022: Virtual public workshop - Drug Development Considerations for the Prevention of Healthcare-Associated Infections - FDA and the Centers for Disease Control and Prevention (CDC) are co-sponsoring this workshop to discuss topics including the current state of development of pathogen-directed products used to prevent healthcare-associated infections, and antimicrobial resistance threats as potential targets for decolonization and pathogen reduction.
-
August 24, 2022: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - During the virtual town hall, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA hosted the final event in this series on August 24, 2022.
-
August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - FDA's Center for Veterinary Medicine (CVM) will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
-
July 19-20, 2022: Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
-
July 14, 2022: FDA Grand Rounds: One Health at FDA: From Concept to Application, 12:00 - 1:00 p.m. ET, presented by CAPT Brianna Skinner, DVM, MPH, DACLAM, of FDA's Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia, DVM, of FDA's Center for Veterinary Medicine (CVM)
-
July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility.
-
June 28, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - To discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. View the recording.
-
June 28, 2022: FDA Drug Topics: Drug Shortages: Root Causes and Potential Solutions webinar - This webinar will provide a general overview of CDER’s Drug Shortages program, current shortage issues, and challenges.
- June 14-15, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET both days) - To discuss (Topic I) amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age, and (Topic II) amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. Recordings: Day 1, Day 2.
- June 9, 2022: FDA Grand Rounds: Some Perspectives on Data Science and Coronaviruses (virtual), 9:00 - 10:00 a.m. ET - Presented by Seshadri S. Vasan from CSIRO, Australia's science agency, including updates on some FDA-funded research.
- June 7-9, 2022: Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration (webcast)- To discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers.
- June 7, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m.) - To discuss an EUA request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older.
- June 6-10, 2022: Regulatory Education for Industry (REdI) Annual Conference 2022 (virtual) - 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, and also create awareness of current activities, including a plenary session on some of FDA’s noteworthy milestones and landmark accomplishments during the COVID-19 response. View the Day 1 replay on YouTube (keynote presentations begin at 29:39).
- May 24-25, 2022: FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More (webcast) - To present best practices and use cases for successfully bringing forward evidence generated through translational science for regulatory submissions. Stakeholders will discuss ways that translational science can contribute to drug development programs (e.g., surrogate endpoints, enrichment biomarkers, biodynamic/response biomarkers), what some of the challenges are (e.g., validating biomarkers, establishing analytic validation, obtaining biosamples) and strategies to address those challenges (e.g., public-private partnerships, collaborations between industry and academia).
- April 28-29, 2022: 2022 Sentinel Innovation Day and Public Training (virtual) - The Sentinel System is a national electronic system for medical product safety surveillance.
- April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda and Frederick, MD or virtual)
- April 6, 2022: Vaccines and Related Biological Products Advisory Committee Meeting (virtual) - To discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Also see: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters
- March 23-24, 2022: FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers (virtual, 1:00 - 3:00 p.m. ET both days) - This workshop is intended to develop multi-component biomarker concepts and terminology, to identify areas of conceptual language development through presentation of use cases, and discuss gaps in terminology for concepts and approaches related to multi-component biomarkers.
- March 16-17, 2022: Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - FDA is hosting a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for healthcare facilities considering 3D printing medical devices.
- March 9, 2022: 2022 Next-Gen Filovirus Therapeutics Workshop, 10:00 a.m. - 5:00 p.m. ET, hosted by the Biomedical Advanced Research and Development Authority (BARDA) to discuss medical countermeasure approaches to address severe filovirus infection and eliminate persistent infection in filovirus survivors.
- March 7-9, 2022: FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual) - FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape.
- March 3, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - 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 2022-2023 influenza season.
- February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
- January 26, 2022: 2022 Filovirus Vaccine Development Workshop (virtual) - HHS/ASPR will convene a USG workshop focused on development of medical countermeasures against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Companies, USG interagency partners, and others interested in the topic area are encouraged to attend this workshop. The event is open to the public, but space is limited.
- 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. - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic webinar series.
-
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
- December 7-8, 2021: Clinical Investigator Training Course (CITC) Update, including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
- December 3, 2021: Real-World Data Webinar Series: Data Standards for Drug and Biological Product Submissions Containing Real-World Data, hosted by the Reagan-Udall Foundation for the FDA, 1:00 - 2:00 p.m. ET
- November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. (view on YouTube)
- November 16, 2021: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (virtual) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level. (FR notice)
- November 9, 2021: FDA CERSI Lecture on Long COVID: Risk factors, Symptomology and Patient Reported Outcomes, presented by by Dr. Erica Spatz & Dr. Kelli O’Laughlin, 3:00 - 4:00 p.m. ET (virtual)
- November 8 - 9, 2021: 13th Annual Sentinel Initiative Public Workshop - This virtual public workshop will highlight milestones and strategic initiatives underway to enhance and build a more robust Sentinel Initiative. Stakeholders will discuss opportunities to utilize Sentinel’s existing data, infrastructure, and technology.
- November 3-4, 2021: BARDA Industry Day (virtual) - FDA's Elizabeth Sadove, JD, will present on emergency use authorities.
- October 26, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet in open session to discuss Pfizer Inc.’s request to amend its EUA to allow for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
- October 14-15, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - VRBPAC will discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
- October 5, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA webinar, 1:00 - 2:00 p.m. ET - FDA will: 1) Discuss enhanced drug distribution security requirements that go into effect in 2023 under the Drug Supply Chain Security Act (DSCSA); 2) Explain how enhanced drug distribution security will help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful; and 3) Summarize updates on implementation of supply chain security requirements under the DSCSA.
- October 4-6, 2021: 11th Annual Global Summit on Regulatory Science, hosted by FDA's National Center for Toxicological Research - This year's theme is Regulatory Sciences for Food/Drug Safety with Real-World Data & Artificial Intelligence (AI)
- September 30, 2021: The Vaccines and Related Biological Products Advisory Committee will meet in open session (8:30 a.m. - 3:40 p.m. ET, virtual) to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, and the Center for Biologics Evaluation and Research (CBER), and to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.
- September 28, 2021: Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics, 1:00 - 5:30 p.m. ET, virtual - To share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in a public health emergency. More info, including agenda and registration available from Reagan-Udall Foundation for the FDA.
- September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop (virtual), hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required
- September 17, 2021: Vaccines and Related Biological Products Advisory Committee (8:30 a.m. - 3:45 p.m. ET, virtual) - To discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. The meeting will be livestreamed on FDA's YouTube channel and webcast from the FDA website. Also see: FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
- September 9, 2021: Authorities Associated with Respiratory Protection - The Role of NIOSH, the FDA, and OSHA , 3:00 - 4:00 p.m. ET - The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), is hosting a webinar to clarify information regarding U.S. Respiratory Protection authorities, as part of Respiratory Protection Week. Speakers from NIOSH, FDA, and OSHA will discuss the roles of these agencies during conventional operations and emergency response scenarios, and how the respiratory protection landscape has evolved over the last year.
-
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.
- February 26, 2021: Vaccines and Related Biological Products Advisory Committee meeting (webcast) to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. (meeting announcement). Meeting materials now available.
- February 25, 2021: Health Equity and Covid-19: What Minority Communities Need To Know, 6:00 p.m. ET - Join the FDA’s Office of Minority Health and Health Equity for a conversation about health equity and COVID-19 with Dr. Peter Marks and RADM Richardae Araojo. Learn about the latest COVID-19 updates, including information about vaccines and the FDA’s approval process. Please register in advance.
- February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials (remote only) - The Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, is convening this public webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials.
- January 19-20, 2021: Microphysiological Systems: Bridging Human and Animal Research - A Workshop, hosted by the National Academies of Sciences, Engineering, and Medicine - Several FDA speakers will present.
- January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation. CE credit available.
2020 and earlier
-
For events from 2020, please visit this archive page
-
For events from 2019, please visit this archive page
-
For events from September - December 2018, please visit this archive page
-
For events from January - August 2018, please visit this archive page
-
For events from 2017, please visit this archive page
-
For events from 2010-2016, please visit this archive page