Temple: FDASIA Directs FDA To Learn To Use Existing Authority
CDER’s Robert Temple says FDASIA mostly restates existing FDA authority, but also tells the agency it must better communicate what authority it has and how it will use it.
You may also be interested in...
The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.
House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.
A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.