New Generics Team Will Improve Review Efficiency, Consistency
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.
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The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
CDER staff manual outlines seven categories of submissions that can qualify for expedited review, including some ANDAs with patent certifications and supplements that have the potential to create an “extraordinary hardship” for a sponsor if not addressed quickly.
FDA wants to know whether 180-day exclusivity should be revealed up front; question is one of many on ANDA reviews to be considered at September public hearing.