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.

Current news & events

2023 | 2022 | 2021 and earlier 

2023 events

• June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. Also see: Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023

• June 13-14, 2023: 2023 FDA Science Forum (virtual, agenda) - Topic areas include medical countermeasures, infectious disease and pathogen reduction technologies (link to YouTube recording), and product development and manufacturing, including advanced manufacturing. Don't miss the 200+ posters! 

• June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.

• June 8, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss biologics license application (BLA) 761328, for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca AB. The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

• June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 - 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. Please register in advance.

• May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.

• May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual) - To provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early. 

• May 11, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials will testify at a U.S. House Energy & Commerce Health Subcommittee hearing, Preparing for and Responding to Future Public Health Security Threats (10:00 a.m. ET).

• May 4, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials will testify at a U.S. Senate Committee on Health, Education, Labor & Pensions hearing, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act (1:00 p.m. ET)

• May 4, 2023: Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance (1:00 - 3:00 p.m. ET) - For patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance.

• April 27, 2023: Recombinant Protein-Based COVID-19 Vaccines Workshop (virtual, 9:00 a.m. - 1:00 p.m. ET) - Hosted by the Biomedical Advanced Research and Development Authority (BARDA) and FDA, to provide: 1) a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and 2) an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. 
• April 26, 2023: Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency (12:05 - 1:00 p.m. ET) - FDA will host a virtual town hall for COVID-19 test developers to discuss the two final COVID-19 transition guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
• April 25-26, 2023: FDA - United States Pharmacopeia (USP) Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue (Rockville, MD or webcast) - To bring international medical product regulators, multilateral organization representatives, and industry and academic professionals together, to discuss public health priorities, the impact of the COVID-19 pandemic on supply chains, and why the APEC Supply Chain Security Toolkit (PDF, 6.4 MB) continues to be a valuable tool to stakeholders.
• April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - To provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial. This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register. 
• April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - 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, including hands-on training for in-person attendees. 
• April 24-27, 2023: 2023 Preparedness Summit (Atlanta, GA) - The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. (fee) 
• April 18, 2023: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (1:00 - 2:30 p.m. ET) - FDA will host a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices.
• April 17, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The applicant's proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.
• April 13, 2023: Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance (1:00 - 2:30 p.m. ET) - FDA will host a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The draft guidance includes proposed recommendations for the content to include in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an AI/ML-enabled device. A PCCP outlines anticipated device changes and how those changes will be assessed and implemented in accordance with the PCCP, among other things.
• March 30, 2023: Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Public Workshop (virtual) - Immune globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent   hypersensitivity reactions associated with specific lots of IG.  
• March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual) - Hosted by FDA and the Duke-Robert J. Margolis, MD Center for Health Policy, to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcomes measures using DHTs.   
• March 16, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss a New Drug Application (NDA) for Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) for oral use. The proposed indication is treatment of mild-to-moderate coronavirus disease (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is currently authorized for emergency use.
• March 14, 2023: FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop (virtual) - For FDA staff and cell and gene therapy stakeholders to discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products. Please register in advance.
• March 9, 2023: FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools - This presentation by researchers from FDA's National Center for Toxicological Research (NCTR) evaluates a testicular organoid model for use as an in vitro model of Zika virus infection.
• March 7, 2023: Vaccines and Related Biological Products Advisory Committee meeting (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 2023--2024 influenza season.
• February 28-March 1, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of two respiratory syncytial virus (RSV) vaccine Biologics License Applications (BLAs). 
• February 9, 2023: FDA Grand Rounds: A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids (webcast, 12:00 - 1:00 p.m. ET) - Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire antimicrobial resistance genes. In this presentation, Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), introduces an enhanced plasmid subtyping method that not only identifies the genetic elements exclusive to and indicative of a plasmid type, but also characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms.
• February 8, 2023: The House Committee on Energy and Commerce; Subcommittees on Oversight and Investigations and Health will hold a hearing, The Federal Response to COVID-19 (10:00 a.m. ET). FDA Commissioner Dr. Robert M. Califf will testify along with other leaders from across HHS.
• January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations. Also see: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19
• January 12, 2023: Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology 
• Ongoing: Virtual Town Hall Series – Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) - FDA will host regular town halls to share information and answer questions from attendees. Recordings of previous webinars on the policy for mpox tests are available from CDRH Learn, under Specialty Technical Topics. The last event in this series was held March 22, 2023.

2022 events

• December 16, 2022: Machine Learning in Distributed Data Networks like the FDA Sentinel System: Opportunities, Challenges, and Considerations (12:30 - 1:30 p.m. ET, virtual) - To discuss various opportunities for machine learning in distributed data networks like the FDA Sentinel System that conduct activities in pharmacoepidemiology and pharmacovigilance and the unique challenges and considerations they face when applying such methods.

• December 15, 2022: Workshop: Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants (virtual, 7:00 - 11:00 a.m. EST) - Hosted by FDA and the European Medicines Agency (EMA) to bring together scientists, clinicians, industry representatives and regulators to discuss alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. This meeting is intended for experts in the field and/or people actively involved in the topic of the meeting. Please register in advance.

• 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. 

• 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. 

2021 and earlier

• For events from 2021, please visit this archive page

• 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 

Related links

• MCMi Regulatory Science Presentations
• MCM-Related Legal and Policy Presentations, Publications and Q&As
• MCMi News Archive
• FDA Meetings, Conferences, Workshops