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MCMi News and Events

Medical countermeasure and public health emergency news and events from FDA and partners

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Featured news and events

  • October 15-16, 2019: BARDA Industry Day - Pre-registration is closed. Limited onsite registration will be available beginning at 7:30 a.m. on October 15. As an alternative, consider registering for an Accelerator Network hybrid video streaming event on October 15. #BARDA2019
  • October 16, 2019: Antimicrobial Drugs Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.
  • October 16, 2019: Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions – Final Guidance, 12:00 - 1:30 p.m. ET

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

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

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

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

  • November 18, 2019: Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop (Silver Spring, MD and webcast) - To discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. Register by November 8, 2019.

  • November 18-19, 2019: Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development (Silver Spring, MD and webcast) - Co-sponsored by FDA, the Infectious Diseases Society of America (IDSA), the National Institute of Allergy and Infectious Diseases (NIAID), and Pew, this workshop will bring together a diverse array of subject matter experts in the fields of infectious diseases (ID), academics and industry and other government bodies to better understand the current state of U.S. based ID trials and how to enhance enrollment and research in such trials. Register by November 14, 2019.

  • November 18-21, 2019: Chemical and Biological Defense Science & Technology (CBD S&T) Conference  (Cincinnati, OH) Hosted by the Defense Threat Reduction Agency (DTRA). FDA's CDR Todd Myers will be presenting as part of a panel on Alternate and Innovative Mechanisms to Conduct Medical Countermeasure Discovery and Development with the Federal Government. Register by November 1, 2019.

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

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

  • March 3-5, 2020: Mitigating the Impact of Blast-related Burn Injuries: From Prolonged Field Care to Rehabilitation and Resilience (Arlington, VA), hosted by the DoD Blast Injury Research Coordinating Office, U.S. Army Medical Research and Development Command, on behalf of the DoD Executive Agent for Medical Research for Prevention, Mitigation, and Treatment of Blast Injuries. Register by 5:00 p.m. ET November 1, 2019.

  • March 31 - April 3, 2020: Preparedness Summit (Dallas, TX) - The Summit offers a unique learning and networking opportunity for current and aspiring emergency management, public health, and healthcare professionals, and their partners, to share perspectives and engage in dialogue on key public health preparedness and response issues.

FDA funding opportunity - In February 2018, FDA revised its Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. MCM-related research submissions are encouraged under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health Security. The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 29, 2019 for fiscal year 2019 awards. More about MCM-related extramural research
  • September 6, 2019: From HHS - HHS has issued RFPs in support of BARDA clinical trials, including contract research organizations to plan and conduct clinical trials (respond by October 21, 2019); establish a new statistical and data coordinating center (respond by October 7, 2019); and support the establishment of a new biospecimen storage facility (respond by October 7, 2019).
  • February 22, 2019: NIAID has posted a BAA for research areas including: Development of Radiation/Nuclear Medical Countermeasures, Development of Therapeutic Products for Antibiotic Resistant Bacteria, and Advanced Development of Vaccine Candidates for Antibiotic Resistant Bacteria.

  • December 3, 2018: From NIH - Antimicrobial Resistance Diagnostic Challenge names five finalists - Selected entrants will receive $100,000 to further develop and test prototypes to improve detection of drug-resistant bacteria or differentiate between a bacterial and viral infection. Antibiotic resistant bacteria are a rising public health threat and cause at least 2 million infections and 23,000 deaths each year in the United States, according to CDC. Drug resistance can also erode the effectiveness of drugs provided as part of a medical response to bioterrorism, such as an anthrax attack. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) are each contributing $10 million to the Challenge. The Challenge also was developed with technical and regulatory expertise from the CDC, FDA, and NIH Office of the Director.

  • May 1, 2018: Slides are now available from FDA Sentinel Industry Day 2018 - also see FDA's Sentinel Initiative

  • November 6, 2017: The HHS Office of Biomedical Advanced Research and Development Authority (BARDA) has issued a Broad Agency Announcement (BAA) seeking proposals for the advanced research and development of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. Respond by October 31, 2019.

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