FDA Medical Countermeasures Initiative Update

Final Animal Rule Guidance

On October 27, 2015, FDA issued a final guidance document: Product Development Under the Animal Rule (PDF, 563 KB). The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible, such as developing medical countermeasures for potential bioterror threats.

Related information

Clinical Trial Designs for Emerging Infectious Diseases

EID clinical trials workshop webcast recording

In partnership with NIAID, the HHS Assistant Secretary for Preparedness and Response (ASPR) and CDC, FDA held a public workshop November 9-10, 2015, to explore the ethical and methodological assumptions behind the choice of different trial designs, describe different types of emerging infectious diseases of concern, and explore several clinical trial designs for both vaccines and therapeutic products.

View the webcast recordings

News updates

Events:

December 1-2, 2015: PDA/FDA Vaccines Conference (Bethesda, MD)

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) - early registration recommended

January 6-7, 2016: PHEMCE Stakeholders Workshop 2016 - registration will close onDecember 11, 2015, or when the event reaches capacity - More about PHEMCE - Public Health Emergency Medical Countermeasures Enterprise

February 3, 2015: Eighth Annual Sentinel Initiative Public Workshop - registration required (Washington, DC and webcast) (Federal Register notice) - more about the Sentinel Initiative

View more events on the frequently updated MCMi News and Events page

Preparedness and response:

From the White House: A National Biosafety and Biosecurity System in the United States(October 29, 2015) and We’ve Reached a Major Milestone in the Fight Against Ebola(November 12, 2015) - also, during the G-20 Leaders’ Summit in Antalya, Turkey, President Obama announced that the United States and 30 countries have made a commitment to work together to achieve the targets of the Global Health Security Agenda (November 16, 2015)

HHS to procure two inhalational anthrax treatments for national supply (November 12, 2015)

CDC has updated the State, Tribal, Local & Territorial Public Health Professionals Gateway, an online portal connecting the public health workforce to information, tools, and resources(November 10, 2015)

Guidance and information for industry:

Proposed rule - Federal Policy for the Protection of Human Subjects - comment byDecember 7, 2015

FDA announced a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Submit requests to participate in the REMS SPL pilot by December 7, 2015.

Draft Guidance for Industry - Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF, 113 KB) - comment by December 21, 2015 (Federal Register notice)

Draft Guidance for Industry - Manufacturing Site Change Supplements: Content and Submission (PDF, 684 KB) (CDRH and CBER) - comment by January 19, 2016 (Federal Register notice)

Drug Supply Chain Security Act (DSCSA) Implementation: Product Tracing Requirements for Dispensers—Compliance Policy (PDF, 58 KB) - Update: compliance deadline extended to March 1, 2016 (Federal Register notice) (November 2, 2015)

How to submit comments

Funding opportunities and other deadline reminders:

Small U.S.-based companies developing countermeasures to protect healthy tissue from the effects of radiation exposures may be eligible for a unique funding opportunity offered through the National Space Biomedical Research Institute (NSBRI). NSBRI's Industry Forum is soliciting applications for its Space Medical and Related Technologies Commercialization Assistance Program (SMARTCAP ). SMARTCAP grants are used to accelerate the development of products meeting a need on Earth as well as in space.Applications are due November 30, 2015. (via NIAID)

Funding opportunity - NIAID is soliciting responses for administrative and management services support to rapidly establish clinical research collaborations with government, academia and health researchers in response to urgent research demands. Responses are due December 7, 2015.

FDA's Center for Devices and Radiological Health (CDRH) invites medical device industry, academia, and health care facilities to request to participate in the 2015 Experiential Learning Program, a training program for FDA's medical device review staff. Submit requests for participation by December 16, 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

BARDA is accepting BAA responses for the Advanced Research and Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures, Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases, and Advanced Development of Medical Countermeasures for Pandemic Influenza - closing date for applications is October 30, 2017.

In case you missed it:

FDA's Medical Countermeasures Initiative (MCMi) uses a variety of cooperative arrangements to further the development and availability of medical countermeasures. View a new web page listing these agreements, including an October 2015 agreement with Saudi Arabia for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) cooperative regulatory activities.