FDA Generics Office Hopes To Clear Unmeasured ANDAs
This article was originally published in PharmAsia News
The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
You may also be interested in...
With formal review goals weeks away, the Office of Generic Drugs creates a Quality Oversight Team that will help increase and improve application review capacity.
Transition team leaders gain acting director titles, but “long and arduous” reorganization is not yet complete, CDER Director Woodcock notes.
CDER Director Janet Woodcock says when an NDA nears patent expiry and generics are preparing for market entry, reviewers would hand it off to a life-cycle team that would also handle associated ANDAs.