FDA Product Quality Reviews Could Become Team Effort To Improve Consistency
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
The Office of Generic Drugs may evolve to focus more on clinical issues as the new Office of Pharmaceutical Quality creates uniform standards for manufacturing process engineering and other production areas, the CDER director says in an interview.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.