FDA Medical Countermeasures Initiative Update

FDA MCMi Annual Program Update

From FDA Acting Chief Scientist Dr. Luciana Borio:

I am pleased to present the FDA Medical Countermeasures Initiative (MCMi) program update for our fourth year of operations. In addition to our ongoing work to advance the development and availability of medical countermeasures to protect against chemical, biological, radiological, and nuclear (CBRN) threats, we have also responded to emerging public health threats in an unprecedented way.

The Ebola epidemic in West Africa tested systems we’ve been putting in place since MCMi was launched in 2010, including new legal authorities granted by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA); numerous collaborations with industry, academia, government and international partners; and our investments in regulatory science research—research required to facilitate the development of medical countermeasures and inform their use in emergency situations. more

Read the report here.

Related information

Download a printable PDF of the report (1.3 MB)
About PAHPRA, which contains key legal authorities to strengthen the United States’ preparedness for public health emergencies involving CBRN agents and emerging infectious disease threats
About MCMi

News updates

Events:

July 20-21, 2015: NIAID workshop - Bacteriophage Therapy: An Alternative Strategy to Combat Drug Resistance (Rockville, MD) - free, registration required
September 28-30, 2015: 2015 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference - Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions (Washington, DC)

Preparedness and response:

The HHS Assistant Secretary for Preparedness and Response (ASPR) has introduced a new resource, the ASPR Technical Resources Assistance Center and Information Exchange (ASPR TRACIE), a new information gateway that connects public health and medical professionals with the emergency preparedness, response and recovery information they need. (June 15, 2015)

Ebola:

HHS selects nine regional Ebola and other special pathogen treatment centers, and pursues fast, easy test to detect Ebola virus infections (June 12, 2015)
From NIH - Study of Ebola survivors opens in Liberia: Trial to examine long-term health effects of Ebola virus disease (June 17, 2015)

Federally funded research:

Read about an FDA BAA project: Hybrid Genome Sequencing and Assembly of Bacterial Pathogens Using Emerging Innovative Technologies (June 2015)
View presentations and recordings from FDA's Office of Regulatory Science and Innovation Science Symposium, held April 27, 2015, and the 2015 FDA Science Forum, held May 27-28, 2015

Guidance:

FDA has a new Risk Evaluation and Mitigation Strategies site, a centralized, user-friendly source for approved REMS (June 16, 2015)
Final Guidance for Industry - Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (PDF, 313 KB) (June 11, 2015)

Deadline reminders:

The National Library of Medicine announced a funding opportunity for small projects to improve access to disaster medicine and public health information for health care professionals, first responders and others that play a role in health-related disaster preparedness, response and recovery. Proposals due July 6, 2015.
HHS intends to hold a prize competition for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. NIH and BARDA are sponsoring the prize competition, and seek public comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. Comment by July 17, 2015.
FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects