FDA Product Quality Reviews Could Become Team Effort To Improve Consistency
This article was originally published in The Pink Sheet Daily
Executive Summary
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...
FDA Generics Office Hopes To Clear Unmeasured ANDAs
The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision
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.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.