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 past events. Presentations and meeting files linked from this archive page may not contain the latest available information.
Visit MCMi News and Events for current happenings.
- June 27-30, 2016: Second annual Biodefense World Summit (Baltimore, MD), hosted by the Knowledge Foundation (fee)
- June 25-29, 2016: 120th AFDO Annual Educational Conference, (Pittsburgh, PA) hosted by the FDA Philadelphia District Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), and the North Central Association of Food and Drug Officials (fee) (Federal Register notice)
June 23, 2016: FDA will join the HHS Office of Minority Health and CDC in a bilingual (English and Spanish) Zika Twitter chat, 2:00 – 3:00 p.m. ET, #StopZika - follow FDA Twitter accounts @US_FDA, @FDAenEspanol, and @FDA_MCMi
- June 21-22, 2016: The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) is holding a public meeting on topic areas related to incentives for the development of vaccines, diagnostics, and therapeutics, the environment and antibiotic-resistance. (Washington, DC and webcast) There will also be a presentation regarding FDA Guidance for Industry #213, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals (PDF, 115 KB). Register to attend in-person by June 18, 2016.
- June 21, 2016: FSMA Webinar: Final Rule on Mitigation Strategies To Protect Food Against Intentional Adulteration- 11:00 a.m. – 12:00 a.m. ET (please connect by 10:45 a.m.), registration not required
June 20, 2016: OpenFDA Public Workshop (Silver Spring, MD) - The openFDA system user community will engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform. Requests to make app demonstrations must be received by 5:00 p.m. ET, June 6, 2016. (Federal Register notice)
- June 17, 2016: The National Advisory Committee on Children and Disasters (NACCD) and the National Preparedness and Response Science Board (NPRSB) will hold a joint public teleconference.
June 9, 2016: The Antimicrobial Drugs Advisory Committee will hold a public meeting to discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence. (Silver Spring, MD) (Federal Register notice)
June 1, 2016: Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics (Silver Spring, MD, and webcast), jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and FDA - registration required (fee, for some in-person participants)
May 31 - June 2, 2016: NCT CBRNe USA (Arlington, VA), hosted by IB Consultancy (fee)
- May 26, 2016: The National Preparedness and Response Science Board will hold a public teleconference - advance registration required
May 24, 2016: National Science Advisory Board for Biosecurity (NSABB) Meeting (Bethesda, MD and webcast) - register by noon May 14, 2016
May 17-19, 2016: 14th Annual Vaccines & Therapeutics - Biodefense, Antimicrobial Resistance, Emerging Infectious Diseases, hosted by Infocast (Washington, DC) - FDA representatives will present (fee)
May 17-18, 2016: FDA Small Business Regulatory Education for Industry (REdI) Conference (Bloomington, MN)
- May 12, 2016: FDA Grand Rounds webcast - Antibiotic resistance surveillance in the age of genomics: New answers to old questions, presented by Patrick F. McDermott, MS, PhD, FDA Center for Veterinary Medicine
- April 25-29, 2016: Achieving Data Quality and Integrity in Maximum Containment Laboratories course (Bethesda, MD), hosted by FDA and the University of Texas Medical Branch - Galveston National Laboratory - the course covers how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level laboratory facilities (BSL-4).
- April 25-27, 2016: DIA/FDA Statistics 2016 Forum (Bethesda, MD) discussing timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics (fee)
- April 19-22, 2016: Preparedness Summit (Dallas, TX), hosted by the National Association of County and City Health Officials (NACCHO) (fee) - includes a Medical Countermeasures Link workshop to provide federal updates for state strategic national stockpile and local MCM coordinators
April 18-20, 2016: 19th Annual Conference on Vaccine Research (Baltimore, MD), hosted by the National Foundation for Infectious Diseases (fee)
April 14-15, 2016: Public Workshop: Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification, (Bethesda, MD) co-hosted by FDA and the National Institutes of Health Biomarkers Consortium - event is at capacity, but webinar registrations still available (Federal Register notice)
April 14, 2016: Update on FDA’s Role in Regulatory Oversight of LDTs (webinar), hosted by the Association of Public Health Laboratories and the American Society for Clinical Laboratory Science - Alberto Gutierrez, PhD, Director of the FDA Office of In Vitro Diagnostics and Radiological Health, will discuss FDA’s latest thoughts on laboratory-developed tests (LDTs) regulatory oversight (fee)
April 13-14, 2016: Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies (Bethesda, MD and webcast) - the purpose of this workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies (Federal Register notice)
- April 13, 2016: FDA will join other public health experts in a Zika Twitter chat hosted by Reuters, 2:00 - 3:00 p.m. ET, #ReutersZika
- April 6, 2016: Improved Access to Pathogen Safety Data (PSD) for Infectious Disease Preparedness Programs, webinar hosted by NIH
- April 5-6, 2016: Public Workshop: Proposed Pilot Project(s) under the Drug Supply Chain Security Act (Silver Spring, MD and webcast) - this event has reached capacity; certain portions of the meeting will be available via live webcast
April 1, 2016: CDC is hosting a one-day Zika Action Plan Summit (Atlanta, GA) as the nation faces likely local mosquito-borne transmission of Zika virus in some places in the continental United States. Presentations, webcast recordings, and resources from this event, and a transcript of the summit press conference are now available.
March 31, 2016: Navigating CDER: What You Should Know for Effective Engagement (Silver Spring, MD) - public workshop to help the public and patient advocacy groups gain a better understanding of how to effectively engage FDA's Center for Drug Evaluation and Research (CDER) (Federal Register notice)
March 30-31, 2016: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) public meeting (Washington, DC and webcast) - written comments must be received, and in-person attendees must register by March 21, 2016 (Federal Register notice)
- March 29, 2016: From Ebola to Zika - What do Providers Need to Know? Experts from CDC, the US military, and a Florida health system will share their viewpoints in a free webinar, hosted by Modern Healthcare
- March 28-29, 2016: Zika Virus in the Americas: An HHS Expert Consultation to Accelerate the Development of Countermeasures, co-sponsored by HHS, NIH, CDC, BARDA, and FDA (Rockville, MD and webcast) - The workshop will review current information about the virus’ epidemiology (including potential link to microcephaly), and clinical manifestations and pathogenesis of Zika virus. There will also be discussion of strategies to accelerate the development of vaccines, diagnostics, therapeutics and novel vector control methods and ensure blood supply safety. View the agenda - Register to attend in-person - Register to attend via webinar
March 22-23, 2016: 4th Annual Joint Civil & DoD CBRN Symposium (Alexandria, VA), hosted by the Defense Strategies Institute (fee)
- March 18, 2016: Zika Preparedness and Response: A Public Health and Legal Perspective webinar, hosted by CDC and several legal organizations - Speakers will provide an overview of the public health problem posed by Zika, including disease characteristic basics and current guidance for healthcare providers, discuss the domestic legal framework for addressing the virus, including a discussion of executive powers for mosquito abatement, and highlight ways to coordinate health care and public health legal preparedness efforts.
- March 16, 2016: Resistance: The Antibiotics Challenge (Washington, DC), hosted by The Atlantic - presenters included Dr. Bill Flynn, Deputy Director for Science Policy in FDA’s Center for Veterinary Medicine
- March 15-18, 2016: FDA/Xavier University PharmaLink Conference (Cincinnati, OH) - this conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials, global regulators, and industry experts (fee) (Federal Register notice)
- March 13-17, 2016: 251st American Chemical Society National Meeting & Exposition (San Diego, CA) (fee) – MCMi’s Dr. Robert Fisher presented on Challenges to the Development of Countermeasures to Chemical and Biological Warfare Agents (presentation to be added)
March 10-11, 2016: Gain-of-Function (GOF) Research: The Second Symposium - the National Academies of Sciences, Engineering, and Medicine will hold a public symposium on potential U.S. government policies for GOF research. This will be the Academies' second meeting to provide a mechanism to engage the life sciences community and the broader public and solicit feedback on optimal approaches to ensure effective federal oversight of GOF research as part of a broader U.S. government deliberative process. FDA's Dr. Robert Fisher will participate in the March 11, 2016 panel Best Practices to Inform National Policy Design and Implementation: Perspectives of Key Stakeholders in the Biomedical and Public Health Communities. Agenda (PDF, 114 KB)
- March 10, 2016: FDA Grand Rounds - The Host Response to Pertussis Infection and Vaccination (webcast), presented by Tod Merkel, PhD, Principal Investigator in FDA's Center for Biologics Evaluation and Research (CBER). The FDA Grand Rounds is webcasted every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.
March 9-10, 2016: Educational Conference Co-Sponsored With the Society of Clinical Research Associates (SOCRA) (San Diego, CA) - The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. (fee)
- March 4, 2016: 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 the influenza virus vaccines for the 2016-2017 influenza season (Federal Register notice)
March 3, 2016: Advancing the Development of Biomarkers in Traumatic Brain Injury (Silver Spring, MD and webcast) - This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). (Federal Register notice) - webcast recordings now available
- March 2, 2016: FDA Assistant Commissioner for Counterterrorism Policy and Acting Chief Scientist Dr. Luciana Borio joined other expert witnesses in a hearing on Examining the U.S. Public Health Response to the Zika Virus, House Energy and Commerce Committee, Subcommittee on Oversight and Investigations - read Dr. Borio's testimony
March 1, 2016: Standardizing MERS-CoV Animal Models: Current Status and the Path to Clinical Trials for Vaccines and Therapeutics (Rockville, MD) - Presentation by Dr. Robert Fisher, MERS- CoV Regulatory Questions (PDF, 112 KB)
February 16-17, 2016: Risk Communication Advisory Committee meeting (Silver Spring, MD and webcast) - the Committee discussed recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications
February 16, 2016: Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus: A Workshop (Washington, DC), hosted by the Institute of Medicine
- February 12, 2016: CDC Twitter chat on Zika virus, 11:00 a.m. - 12:00 p.m. EDT - #CDCchat - follow @CDCgov
February 9, 2016: FDA hosted a webinar, Introduction to FDA’s MedWatch Adverse Reporting Program, for healthcare professionals and students on how to report adverse events to FDA MedWatch, and where to find clinically relevant information from Medwatch - more about MedWatch
- February 8-10, 2016: ASM Biodefense and Emerging Diseases Research Meeting (Arlington, VA) (fee) - presentation by Dr. Tracy MacGill on The FDA Animal Rule (PDF, 180 KB)
February 4, 2016: Preparing Youth for Disasters webinar, hosted by FEMA
- January 30 - February 1, 2016: 14th CDC International Symposium on Biosafety (Atlanta, GA), focusing on biosafety management
- January 26-28, 2016: 20th Food and Drug Administration International Separation Science Society Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP 2016) (Washington, DC) - attendees will discuss development of biotechnology-derived drug products and analytic methodologies for the development of biotechnology-derived drug products (Federal Register notice) (fee)
- January 21, 2016: FDA webinar to discuss the final guidance Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - transcript (PDF, 241 KB) - also see the final guidance document (PDF, 319 KB) issued December 9, 2015
January 20-21, 2016: Public workshop - Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Silver Spring, MD and webcast) - More about cybersecurity of medical devices
January 14, 2016: The Vaccines and Related Biological Products Advisory Committee will meet in open session via teleconference to hear updates of the research program in the Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA.
- January 13, 2016: The Neglected Dimensions of Global Security: A Framework to Counter Infectious Disease Crises - webcast featuring an overview of findings from the Commission on a Global Health Risk Framework for the Future, hosted by the National Academy of Medicine
- January 7-8, 2016: National Science Advisory Board for Biosecurity (NSABB) meeting (Bethesda, MD and webcast)
- January 6-7, 2016: PHEMCE Stakeholders Workshop 2016 - agenda (PDF, 648 KB) - FDA presentations:
Industry Partnerships: Linking the scientific and regulatory environments (PDF, 1.6 MB) - includes an MCM regulatory science overview, CBER MCM research and a case study on prolonging anthrax vaccine shelf life, determining MCM dose in special populations (CDER), and a regulatory perspective on infectious disease diagnostics and the FDA-ARGOS database
Beyond The Last Mile: MCM Monitoring and Assessment during Public Health Emergencies - What capabilities do we need? (PDF, 525 KB) - presented by HHS/ASPR and FDA
Monitoring and Assessment: FDA’s Role (PDF, 231 KB)
- December 8, 2015: Webinar - Hospital Legal Preparedness: Understanding the Role of the Law When Hospitals Face Emergencies - hosted by the Association of Healthcare Emergency Preparedness Professionals
- December 2, 2015: Workshop - Clinical Trials: Assessing Safety and Efficacy for a Diverse Population, hosted by FDA and the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) (Silver Spring, MD)
December 1-2, 2015: PDA/FDA Vaccines Conference (Bethesda, MD)
- November 19, 2015: Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program (public webcast)
November 18, 2015: Science Board to the FDA meeting (Silver Spring, MD and webcast ) - discussion topics include the ORA Food Emergency Response Network Evaluation Subcommittee, precision medicine and laboratory safety
November 18, 2015: 2:00-4:00 pm ET CDC Get Smart About Antibiotics Twitter chat. Participate with #Antibiotic Resistance and follow @CDCgov and @DrFriedenCDC.
November 18, 2015: Addressing Antimicrobial Resistance through Vaccines webinar from the National Foundation for Infectious Diseases (pre-registration required)
- November 17-18, 2015: Association of Healthcare Emergency Preparedness Professionals (AHEPP) 1st Annual Conference (Omaha, NE) - A new professional association dedicated to advancing the field of disaster preparedness and response, AHEPP, is accepting members and announces their first national conference.
November 13, 2015: Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants (Silver Spring, MD and webcast) - register by October 30, 2015 - related blog post
November 13, 2015: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and webcast) - the committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant
November 13, 2015: The HHS National Advisory Committee on Children and Disasters (NACCD) will hold a public meeting by teleconference.
- November 12, 2015: Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests (Silver Spring, MD and webcast) - register by October 30, 2015 - related blog post
November 9-10, 2015: Public Workshop - Clinical Trial Designs for Emerging Infectious Diseases (Bethesda, MD and webcast) - The Ebola epidemic has highlighted the importance of rapidly evaluating investigational products during a public health emergency. This workshop will explore the ethical and methodological assumptions behind the choice of different trial designs, describe different types of emerging infectious diseases of concern, and then explore several clinical trial designs for both vaccines and therapeutic products. Webcast recordings and transcripts are available.
- November 5, 2015: Joint meeting of the Antimicrobial Drugs Advisory and Drug Safety and Risk Management Advisory Committees (Silver Spring, MD and webcast)
November 4-5, 2015: FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference (Boston, MA), hosted by the Society of Clinical Research Associates
- November 2, 2015: U.S. Department of Defense Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) will host an Industry Day (Fairfield, NJ)
- October 30, 2015: Modernizing the Regulatory System for Biotechnology Products: First Public Meeting (Silver Spring, MD and webcast)
- October 23, 2015: FDA Acting Chief Scientist Dr. Luciana Borio presented Ebola and the "new normal" at TEDxUSU (Logan, UT)
- October 20-23, 2015: Filovirus Medical Countermeasures Workshop (Fort Detrick, MD), hosted by FANG - Presentations and transcripts are now available
October 20, 2015: HHS is holding a public Town Hall Meeting to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) that HHS and 15 other federal departments and agencies published in the Federal Register on September 8, 2015. The purpose of the public Town Hall meeting is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM during the open public comment period in order to clarify the NPRM proposals and better inform public comment on the NPRM.
- October 19, 2015: FDA Acting Chief Scientist Dr. Luciana Borio presented The Global Efforts to Fight Ebola – Then, Now and the Future at the PDA 10th Annual Global Conference on Pharmaceutical Microbiology (Bethesda, MD)
- October 16, 2015: Public workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use (Silver Spring, MD and webcast) - The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. On-site registration available (seating is limited); send requests to view webcast by October 15, 2015.
- October 14-16, 2015: BARDA Industry Day (Washington, DC)
- October 7-8, 2015: CDC Office of Public Health Preparedness and Response Board of Scientific Counselors meeting (FR notice)
October 7, 2015: HHS Public Forum on Developing Rapid Diagnostics to Combat Antibiotic-Resistant Bacteria (San Diego, CA) - provide input on the types of diagnostics that may be developed to combat the growth and spread of antibiotic resistant bacteria - NIH/BARDA public consultation agenda, October 7, 2015 (PDF, 227 KB)
October 5-6, 2015: Public meeting - Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access (Federal Register notice) - read more about REMS
- September 30, 2015: America's PrepareAthon National Day of Action
September 30, 2015: Public meeting - Collecting On-Farm Antimicrobial Use and Resistance Data (Washington, DC) - register by September 18, 2015 (Federal Register notice)
September 29-30, 2015: Public workshop - Medical Device Patient Labeling (Silver Spring, MD and webcast) - register to attend in person or online by September 21, 2015, 4:00 p.m. ET
- September 29, 2015: CDC Public Health Grand Rounds - Shifts in Global Health Security: Lessons from Ebola
- September 29, 2015: Webinar - Get to Know ClinicalTrials.gov hosted by the FDA Office of Minority Health - FAQs (PDF, 336 KB) - slides (PDF, 2.8 MB) - webinar recording (video, 58:07)
- September 29 2015: Webinar - FDA Online Drug Information Resources for Students and Clinicians - Lesley Navin RN, MSN, Advanced Practice Nurse, will present information regarding FDA databases that are of interest to students and practicing clinicians who will learn how to navigate and utilize these databases to find useful, relevant and current drug information - hosted by CDER's Office of Communication, Division of Drug Information
- September 28-30, 2015: 2015 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference - Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions (Washington, DC)
- September 28, 2015: FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data (Silver Spring, MD and webcast) - The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. Register by September 18, 2015.
- September 18, 2015: 2015 FDA Science Writers Symposium - a special event intended to engage and inform science and health journalists about how the FDA is applying scientific approaches to critical public health issues - registration is free and open to credentialed media - register by September 14, 2015
September 17, 2015: ICAAC/ISID Joint Symposium: Emerging Infectious Diseases in the Time of Ebola (San Diego, CA), hosted by the International Society for Infectious Diseases (ISID), in collaboration with the American Society for Microbiology (ASM). This symposium is part of the ASM Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) September 17-21, 2015.
- September 16, 2015: (rescheduled) The DoD Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) will host an Industry Day regarding candidate technologies for the Joint CBRNE Advanced Capability Sets (JCACS) Advanced Technology Demonstration (ATD). (FedBizOpps RFI - respond by August 17, 2015)
September 15, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. (Federal Register notice)
September 15, 2015: The Science Board to the FDA will meet via webcast to discuss a report from the Science Looking Forward subcommittee
- September 11, 2015: Public workshop, hosted by FDA and M-CERSI - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy (College Park, MD) (fee)
September 3, 2015: #Prep4Moms Twitter Chat: Emergency Preparedness for Moms and Little Ones, 1:00 - 2:00 p.m. EDT, hosted by the HHS Office of the Assistant Secretary for Preparedness and Response, and the HHS Administration for Children and Families
- August 31, 2015: FDA and the National Oceanic and Atmospheric Administration (NOAA) will host a webinar - Food Safety: Bad Weather Basics at 11:00 a.m. ET - presentation slides (PDF, 1.8 MB)
- August 27, 2015: Meeting of the National Advisory Committee on Children and Disasters (NACCD) (teleconference) - pre-registration is required for public attendance - to register, use this form
August 24-26, 2015: International Conference on Emerging Infectious Diseases (Atlanta, GA)
- August 24-26, 2015: FEMA MADT course - A 3-day course designed to prepare state and local public health staff to implement mass dispensing training for their agencies or jurisdictions
- August 21, 2015: Public workshop: Evidentiary Considerations for Integration of Biomarkers in Drug Development (Baltimore, MD) - attendees will discuss current scientific approaches to biomarker development, acceptance, and utility in drug and biologic development programs. Hosted by FDA, in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation and the Critical Path Institute. Registration required (fee).
- August 24, 2015: Quality Metrics Public Meeting - The public meeting and draft guidance (PDF, 250 KB) are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry. Register by August 7, 2015. Read an FDA Voice blog post about Quality Metrics.
- August 10-14, 2015: Northwest Tribal Emergency Management Council - 2nd Annual National Tribal Emergency Management Conference (Spokane, WA) - registration open
- August 10-12, 2015: FEMA SNS Preparedness course - A 3-day course on the Strategic National Stockpile for public health officials on how to design and execute MCM mass distribution and dispensing operations
- August 10-11, 2015: HHS Hurricane Sandy Conference: Translating Research into Practice (New York, NY)
- July 29, 2015: Science Board to the FDA meeting (Silver Spring, MD and webcast) - meeting materials
July 20-21, 2015: NIAID workshop - Bacteriophage Therapy: An Alternative Strategy to Combat Drug Resistance (Rockville, MD) - free, registration required
- July 17, 2015: NIH CounterACT webinar - The NIH Countermeasures Against Chemical Threats (CounterACT) program supports research on the development of new and improved medical countermeasures designed to prevent and treat the conditions caused by acute exposure to chemical agents.
- July 7-9, 2015: National Association of County and City Health Officials (NACCHO) annual conference (Kansas City, MO)
- July 7, 2015: FDA Food Safety Challenge Demo Day (College Park, MD and webcast)
June 30, 2015: Emergency Planning With Pharmacies (webinar) - hosted by the National Association of County and City Health Officials (NACCHO)
- June 23, 2015: FEMA webinar - Getting Youth Involved in Emergency Preparedness
- June 22-26, 2015: Biodefense World Summit (Bethesda, MD), including tracks on biodetection technologies (pathogen and biothreat detection, and point-of-care for biodefense) and biosurveillance integration - hosted by the Knowledge Foundation
- June 20-24, 2015: In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation (Indianapolis, IN), hosted by the Association of Food and Drug Officials
- June 16, 2015: Ethics and Ebola - Public Health Planning and Response webinar, hosted by the Presidential Commission for the Study of Bioethical Issues - webinar recording
- June 14-18, 2015: DIA 2015 51st Annual Meeting (Washington, DC) - FDA's Dr. Luciana Borio discussed FDA's point of view in the forum New Pandemics: Lessons Learned from the Ebola Experience
June 5, 2015: GDUFA FY 2015 Regulatory Science Initiatives Part 15 public meeting (Silver Spring, MD and webcast) - current status of regulatory science initiatives for generic drugs and opportunity for public input
June 4-5, 2015: IOM meeting (Washington, DC) - First meeting of the Standing Committee for the Centers for Disease Control and Prevention Division of Strategic National Stockpile
- June 2-4, 2015: 13th Annual Vaccines & Therapeutics - Biodefense, Antimicrobial Resistance, Emerging Infectious Diseases (Washington, DC), hosted by Infocast, Inc.
June 1-3, 2015: ISPE/FDA/PQRI Quality Manufacturing Conference (Washington, DC) - hosted by the International Society for Pharmaceutical Engineering, the Product Quality Research Institute, and FDA (Federal Register notice)
- May 27-29, 2015: FEMA MADT course - A 3-day course designed to prepare state and local public health staff to implement mass dispensing training for their agencies or jurisdictions
May 27-28, 2015: FDA Science Forum (Silver Spring, MD and webcast) - This year's FDA Science Forum included medical countermeasure-related regulatory science topics. The focus of this year's Forum was FDA's eight regulatory science priority areas - agenda
- May 14-15, 2015: Medical Devices Advisory Committee - Gastroenterology and Urology Devices Panel discussed recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes (Silver Spring, MD and webcast) (Federal Register notice)
May 13-14, 2015: FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference (Cincinnati, OH), hosted by the Society of Clinical Research Associates
- May 12, 2015: The FDA Vaccines and Related Biological Products Advisory Committee met in open session to discuss the development and licensure of Ebola vaccines (Silver Spring, MD and webcast) (Federal Register notice) - Agenda (PDF, 52 KB) - Briefing Document: Licensure of Ebola Vaccines: Demonstration of Effectiveness (PDF, 146 KB) - additional meeting materials will be posted here when available
May 8-11, 2015: 4th ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens (Washington, DC), hosted by the American Society for Microbiology
- May 7, 2015: National Academy of Sciences Standing Committee on Support to the Department of Defense’s Programs to Counter Biological Threats - Biosurvellance: From Data to Actions to Impact (Washington, DC) - register - agenda (PDF, 299 KB)
- May 5-7, 2015: 2015 EPA International Decontamination Research and Development Conference (Research Triangle Park, NC) - The conference is designed to facilitate presentation, discussion, and further collaboration on research and development focused on an all-hazards approach to cleaning up contamination, especially chemical, biological, and radiological threat agents - register by April 24, 2015
- May 4-7, 2015: National Interagency Confederation for Biological Research (NICBR) Spring Research Festival (Fort Detrick, MD) - schedule of events - The Spring Research Festival is open to NICBR partners and invited guests. Appropriate clearance must be obtained to access the base.
- May 4-6, 2015: FEMA SNS Preparedness course - A 3-day course on the Strategic National Stockpile for public health officials on how to design and execute MCM mass distribution and dispensing operations
- April 30, 2015: Meeting of the HHS National Advisory Committee on Children and Disasters (teleconference) (Federal Register notice)
- April 27-May 1, 2015: FDA-sponsored course (a collaboration with UTMB): Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD)
- April 27, 2015: FDA Basics webinar - Drug Trials Snapshots
- April 27, 2015: FDA Office of Regulatory Science and Innovation (ORSI) Science Symposium (Silver Spring, MD and webcast)
- April 25-28, 2015: Association of Clinical Research Professionals (ACRP) 2015 Global Conference & Exhibition (Salt Lake City, UT) - FDA's Dr. Luciana Borio participated in a panel: Ebola and Other Emerging Pathogens - A New Challenge for Research and Healthcare
- April 24, 2015: Public meeting - Breakthrough therapy designation: Exploring the qualifying criteria (Washington, DC and webcast)
- April 21, 2015: HHS ASPR Twitter chat on student health volunteers, 1:00 - 2:00 p.m. ET #NHSSchat
- April 14-17, 2015: 2015 Preparedness Summit – Global Health Security: Preparing a Nation for Emerging Threats (Atlanta, GA) - FDA experts presented on topics including federal updates on emergency use of medical countermeasures (MCMs), mobile technologies and MCM adverse event reporting, cyber security for medical devices, and best practices for food-related emergencies - MCM legal presentations
- April 13-15, 2015: National Foundation for Infectious Diseases 18th Annual Conference on Vaccine Research (Bethesda, MD)
- March 31, 2015: Webinar – PHEMCE: Federal Support for Medical Countermeasure Development and Delivery - hosted by HHS ASPR, NACCHO and ASTHO
- March 31, 2015: FCC and FDA joint workshop - Promoting Medical Technology Innovation - the Role of Wireless Test Beds (Washington, DC and webcast)
- March 30, 2015: Meeting of the National Preparedness and Response Board (public teleconference) (Federal Register notice)
March 26-27, 2015: IOM workshop: Enabling Rapid Medical Countermeasures Research, Discovery, and Translation to Emerging Threats Workshop - free and open to public
March 24-25, 2015: IOM Forum on Microbial Threats meeting: Ebola Epidemic in West Africa (Washington, DC) - free and open to public
March 17, 2015: CDC Grand Rounds - Addressing Preparedness Challenges for Children in Public Health Emergencies (webcast, 1:00 p.m. EDT)
March 16-17, 2015: 3rd Annual Joint Civil & DoD CBRN Symposium, hosted by the Defense Strategies Institute (Alexandria, VA)March 11-12, 2015: FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference (San Francisco, CA), hosted by the Society of Clinical Research Associates
March 10, 2015: Webinar for pharmacy and healthcare students - Introduction to Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
- March 5, 2015: Harvard Medical School forum - Rethinking the Response to Emerging Microbes: Vaccines and Therapeutics in the Ebola Era (Boston, MA) - FDA participated in a panel on scientific and regulatory issues limiting development of Ebola vaccines and therapeutics - #EbolaForumHMS
March 4, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD) - The committee met in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.
- February 26, 2015: HHS National Advisory Committee on Children and Disasters public meeting (teleconference) (Federal Register notice)
February 24, 2014: Webinar for pharmacy and healthcare students - Introduction to FDA's MedWatch Adverse Reporting Program - download the presentation slides (PDF, 2.8 MB)
February 20, 2015: Public workshop - Optimizing FDA's Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests (Bethesda, MD and webcast)
February 18-20, 2015: FEMA SNS Preparedness course - A 3-day course on the Strategic National Stockpile for public health officials on how to design and execute MCM mass distribution and dispensing operations
February 9-11, 2015: ASM Biodefense and Emerging Diseases Research Meeting (Washington, DC)
Feburary 9, 2015: CDER webinar - The Requirements to Provide Regulatory Submissions in Electronic Format - Standardized Study Data - The webinar provided an overview of the final guidances and related technical specifications that implement the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). Presentations and slides available at link above.
February 5-6, 2015: Presidential Commission for the Study of Bioethical Issues public meeting (Washington, DC and webcast) - The Commission will begin discussions about the ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic. FDA's Dr. Luciana Borio will co-present a session "Ethical Issues Associated with Research in the Context of a Public Health Emergency" - agenda - webcast recording (Federal Register notice)
February 5, 2015: 7th Annual Sentinel Initiative Public Workshop (Washington, DC) - Participants discussed a variety of topics on active medical product surveillance, including an overview of the transition from the Mini-Sentinel pilot program to the full Sentinel System, and what that means for patients and other stakeholders. (Federal Register notice) - webcast recording
- February 2-5, 2015: USDA Agricultural Research Service (ARS) 3rd International Biosafety & Biocontainment Symposium (Baltimore, MD)
January 8-9, 2015: Public workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Bethesda, MD and webcast)
January 8, 2015: Threat Day 2015 (Washington, DC), hosted by the Combating Terrorism Technical Support Office [This event was only open to U.S. government employees, their SETA support contractors and representatives from the governments of the United Kingdom, Singapore, Israel, Australia, and Canada.]
January 7, 2015: Oncologic Drugs Advisory Committee meeting (Silver Spring, MD) - The committee discussed biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to NEUPOGEN (filgrastim).
December 12, 2014: Public workshop: Immunology of Protection from Ebola Virus Infection (Rockville, MD and webcast) - The purpose of this workshop was to discuss important aspects of Ebola virus and vaccine immunology in order to inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola. Webcast recording (7 hours, 32 minutes)
December 4, 2014: Anti-Infective Drugs Advisory Committee (Hyattsville, MD) - The committee discussed issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.
November 20, 2014: FDA Basics Webinar: FDA CBER Mini-Sentinel Program (webcast, 3:00 p.m. EST)
November 18-20, 2014: NATO Advanced Research Workshop on Preparedness for Nuclear & Radiological Threats (Los Angeles, CA)
November 19-20, 2014: Science Board to the FDA (Silver Spring, MD and webcast)
November 19, 2014: Testimony: FDA's Dr. Luciana Borio spoke as part of a panel on Examining Medical Product Development in the Wake of the Ebola Epidemic (House Committee on Energy and Commerce, Subcommittee on Health hearing)
November 17-21, 2014: POSTPONED - 2014 Chemical and Biological Defense Science and Technology (CBD S&T) Conference: Finding Tomorrow’s Solutions in Today’s Environment (St. Louis, MO) - to be notified of updates, register for the conference mailing list
November 5, 2014: FDA's Dr. Luciana Borio and Dr. Edward Cox presented as part of a panel discussion "The Ebola Outbreak: How Do We Identify Effective Interventions?" and participated in a media briefing on Ebola at the American Society of Tropical Medicine and Hygiene Annual Meeting (New Orleans, LA). Media briefing details: view the full list of speakers (PDF, 269 KB), and listen to the recording (1 hour, 14 minutes).
November 4, 2014: CDRH Industry Basics Workshop - webinar covering the fundamental concepts of medical device regulations - view presentations from this webinar, including IDE basics, 510(k), De Novo program, CAPA basics, and medical device reporting (21 CFR Part 803)
November 4-6, 2014: FDA's Clinical Investigator Training Course (College Park, MD)
November 3, 2014: Institute of Medicine workshop: Research Priorities to Inform Public Health and Medical Practice for Domestic Ebola Virus Disease (Washington, DC)
October 29, 2014: Webinar - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Final Guidance - recorded webinar (video/audio), printable slides (PDF, 227 KB), transcript (PDF, 256 KB)
October 21-23, 2014: 16th Annual NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Conference (Albuquerque, New Mexico)
October 21-22, 2014: Public Workshop - Collaborative Approaches for Medical Device and Healthcare Cybersecurity (Silver Spring, MD) - webcast recordings, slides and transcripts available
October 21, 2014: Safety Pharmacology Society 14th Annual Meeting (Washington, DC) - Presentation by Dr. Tracy MacGill, Challenges in Approval of New Treatments in the Biodefense World (PDF, 233 KB)
October 16-17, 2014: Public Health Law Conference (Atlanta, GA) - FDA and HHS speakers discussed the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), including new personnel and medical countermeasure flexibilities for public health emergency response. FDA presentations (PDF, 318 KB)
October 15-17, 2014: BARDA Industry Day (Washington, DC)
October 8-9, 2014: Public Workshop - Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing (Silver Spring, MD)
September 26-30, 2014: 2014 International Poxvirus, Asfarvirus & Iridovirus Conference (Victoria, British Columbia, Canada)
September 24-25, 2014: Workshop - Next -Generation Sequencing Standards (Bethesda, MD and webcast)
September 22-24, 2014: NIAID Public Workshops - Addressing Challenges in Antimicrobial Resistance , including Overcoming Bottlenecks in Antibacterial Product Development (September 22-23) and Coordinated Development of Diagnostics and Therapeutics (September 23-24) (Rockville, MD)
September 23, 2014: FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio participated in a symposium entitled The Ebola Crisis: Context, Systemic Challenge, Consequences. Dr. Borio discussed FDA’s role in responding to the outbreak. The meeting was hosted by Georgetown University, Washington, D.C., and open to the public.
September 22, 2014: Public Workshop – Pediatric Clinical Investigator Training (Bethesda, MD)
September 17, 2014: Testimony - FDA’s Dr. Luciana Borio spoke as part of a panel on Global Efforts to Fight Ebola (House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations hearing)
September 17, 2014: HHS Twitter chat - Emergency Preparedness for Little Ones , 1:00 - 2:00 p.m. EDT, #Prep4Kids - learn about ways you can help keep kids under 5 healthy before, during and after an emergency
September 5, 2014: Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus aureus in the Healthcare Setting (Silver Spring, MD)
September 4, 2014: POSTPONED -Annual public meeting of the Interagency Task Force on Antimicrobial Resistance (ITFAR) (Washington, DC) (Federal Register notice )
September 3-4, 2014: Public Workshop - Hemostatic Medical Devices for Trauma Use (Silver Spring, MD)
September 3-4, 2014: National Academy of Sciences ILAR Roundtable Workshop: Transportation of Laboratory Animals (Washington, DC)
September 3-5, 2014: Public Workshop - Adverse Outcome Pathways: From Research to Regulation hosted by NIH (Bethesda, MD)
August 12-13, 2014: FDA Public Meeting - 2014 Scientific Meeting of the National Antimicrobial Resistance Monitoring System (Silver Spring, MD)
August 8, 2014: Public Meeting - Inaugural meeting of the HHS National Advisory Committee on Children and Disasters (Washington, DC)
July 30-31, 2014: Public Workshop - The Development of New Antibacterial Products: Charting a Course for the Future, hosted by the National Institutes of Health (NIH) and FDA (Bethesda, MD) - Day 1 presentations , Day 2 presentations
June 4-6, 2014: 12th Annual Emerging Infectious Diseases & Biodefense - Vaccines, Therapeutics, Diagnostics conference (Washington, DC) - FDA presented a special session, "What's New in Medical Countermeasure Science and Policy at FDA" - FDA presentation: MCM policy updates following the 2013 enactment of PAHPRA (PDF, 261 KB)
June 4-5, 2014: National Academy of Sciences ILAR Roundtable Workshop: Reproducibility Issues in Research with Animals and Animal Models (Washington, DC)
May 5-8, 2014: National Interagency Confederation for Biological Research (NICBR) Spring Research Festival at Fort Detrick (Frederick, MD) - visit FDA in booth 127
May 5-6, 2014: Risk Communication Advisory Committee Meeting (FDA Headquarters, Silver Spring, MD)
April 28- May 2, 2014: FDA/UTMB-Sponsored Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF, 273 KB) (Bethesda, MD)
April 25-27, 2014: USA Science & Engineering Festival (Washington, DC) - FDA exhibited in booth #1741 at this free event promoting science, technology, engineering and math (STEM) among our nation's youth
April 4, 2014: NIAID/FDA Workshop on Regulatory Issues Related to Dengue Vaccines (Rockville, MD)
April 1-4, 2014: Preparedness Summit (Atlanta, GA)
April 1, 2014: Public Workshop – Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification andDetection of Antimicrobial Resistance Markers (FDA Headquarters, Silver Spring, MD)
March 20, 2014:Vaccines and Related Biological Products Advisory Committee Meeting (Rockville, MD)
February 26-27, 2014: Neurological Effects after Chemical Nerve Agent Exposures Workshop
February 20, 2014: FSMA Public Meeting: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule – College Park, MD
January 27-29, 2014: ASM Biodefense and Emerging Disease Research Meeting
November 12-14, 2013: BARDA Industry Day: Contracting for Countermeasures
October 17, 2013: Meeting of the Anti-Infective Drugs Advisory Committee to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling
September 25-26, 2013: FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2013
August 22-23, 2013: Filovirus Medical Countermeasure Workshop
March 25, 2013: Register Now for FDA's BAA Industry Day (PDF, 20.12 KB)
February 12, 2013: FDA Public Meeting of Blood Products Advisory Committee where FDA experts will discuss research grant opportunities, including for MCMs, supporting Regulatory Science and Innovation
November 29-30, 2012: Public Workshop on Burkholderia (PDF, 92 KB) 10.25 CEs Offered
November 15 - 16, 2012: Blood Products and Cellular Therapies – A Symposium on Emergency Preparedness
November 14, 2012: Vaccines and Related Biological Products Advisory Committee Public Meeting
November 2, 2012: FDA Anti-Infective Drugs Advisory Committee Public Meeting
October 29 – 31, 2012: BARDA Industry Day - Contracting for Countermeasures
September 2012: Meeting the Challenges of Medical Countermeasure Development , FDA perspectives in recent issue of Microbial Biotechnology.
September 27-28, 2012: Public Workshop on MCM Burn Mass Casualty Incident
September 27-28, 2012: Public meeting, MCM Radiation Biodosimetry Devices, Regulatory Science Considerations; Registration and agenda information available.
September 19, 2012: The Role of Health Research and Regulatory Agencies in Biosurveillance and Biothreat Preparedness (presentation, PDF, 1 MB)
September 6-7, 2012: Public Workshop on Risks and Benefits of Hydroxyethyl Starch Solutions
August 23, 2012: Public Workshop on Use of Influenza Disease Models for Benefit-Risk Evaluation of Vaccines (PDF, 195 KB)
July 24, 2012 : Use of Computer Simulation of the U.S. Blood Supply in Support of Planning for Emergency Preparedness and Medical Countermeasures Public Worshop
June 19-20, 2012: NIAID/FDA Universal Influenza Vaccines Meeting - meeting summary from NIAID (PDF, 316 KB)
June 5-6, 2012: FDA's 2012 MCMi Regulatory Science Symposium
April 30-May 1, 2012: FDA Workshop on Developing Animal Models of Pregnancy to Address Medical Countermeasures for Influenza
March 15, 2012: Public Health Law Webinar Series - Recent Developments in FDA's Emergency Authority for Medical Countermeasures . Presentation slides (PDF, 245 KB)
February 23, 2012: Public Health Preparedness Summit; presentation by MCMi on FDA Anthrax Preparedness (PDF, 836 KB)
February 21, 2012: Workshop - Introduction to Medical Countermeasures: Policy, Products and Practice; presentation by MCMi on FDA's Role in Medical Countermeasures: Current Issues and Challenges (PDF, 582 KB)
February 15-16, 2012: MCM Workshop on Ethical and Regulatory Challenges in the Development of Pediatric MCMs - transcripts
December 14-15, 2011: Advisory Committee meeting on Antiviral Drugs
December 5, 2011: Using Scientific Data to Support Pediatric Medical Device Claims (presentation, PDF, 34 KB)
October 13, 2011: Public Meeting on Highly Multiplexed Microbiology MCM Devices
September 16,2011: Public Workshop on the Development and Evaluation of Next-Generation Smallpox Vaccines and meeting transcript (PDF, 150 KB)
September 12-13, 2011: Public Workshop on Mobile Medical Applications - Draft Guidance
December 14-15, 2010: Federal, State, and Local Public Health Preparedness Legal and Regulatory Meeting