MedicalCountermeasures.gov

MedicalCountermeasures.gov

Information for industry BARDA, a component of the HHS Assistant Secretary of Preparedness and Response (ASPR), is supporting U.S. government market research to identify medical countermeasures with the potential to help address the 2019-nCoV outbreak. If your company is developing 2019-nCoV diagnostics, therapeutics, vaccines, or other products, submit your ideas to BARDA's online portal. FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee (BPAC) for CBER notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the BPAC. Submit materials by February 24, 2020. FDA invites medical device companies, health care facilities, and academia to submit proposals as part of the CDRH Experiential Learning Program (ELP) for regulatory review staff. Submit proposals by 12:00 p.m. ET, February 24, 2020. Funding reminder: Proposers are encouraged to submit white papers to the FDA Broad Agency Announcement (BAA) by 5:00 p.m. ET, March 2, 2020, for FY 2020 awards. MCM-related areas include research and development to support regulatory science and innovation, under Research Area 3: Support new approaches to improve product manufacturing and quality (for example, proposals to support advanced manufacturing for pandemic preparedness and response, or rapidly scale MCM manufacturing capabilities), and Research Area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security. In fiscal year (FY) 2020, FDA is encouraging the submission of chemical defense-related topics under Area 7.