SILVER SPRING, Md., Oct. 14 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases. As outlined in a new white paper, the Initiative will develop an optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.
To solicit feedback on the Rare Disease Framework ...