FDA Generics Office Finalizing Structure As Review Goals Approach
Executive Summary
Transition team leaders gain acting director titles, but “long and arduous” reorganization is not yet complete, CDER Director Woodcock notes.
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.
U.S. Generic Exclusivity Process To Go Public?
The U.S. FDA wants to know whether its 180-day generic exclusivity process should be revealed up front; the question will be one of many on ANDA reviews to be considered at a September public hearing.
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.