FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science   2

Background
The US Food and Drug Administration (FDA) is soliciting for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). The research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. This announcement is a renewal of the prior-year FY21 announcement (FDABAA-21-00123) and will remain open until further notice.

Work Details
The FDA seeks to support advanced research and development strategies with potential for regulatory application in various research areas of interest. The technical objectives include modernizing toxicology to enhance product safety, stimulating innovation in clinical evaluations and personalized medicine, and strengthening the global product safety net. The work involves developing new tools, standards, approaches, clinical trial designs, endpoints, analysis methods, advancing global public health, analyzing and utilizing global data to manage risks, addressing drug shortages, and more. The proposal preparation and submission instructions are contained in Part III of the solicitation.