Home » Woodcock: FDA Hires Consultants to Reduce ANDA Backlog
Woodcock: FDA Hires Consultants to Reduce ANDA Backlog
The FDA has hired an outside consulting firm to help figure out how to reduce its burgeoning stack of generic-drug applications — now reaching more than 2,000. New York-based McKinsey & Company has been brought in to assess the backlog and make recommendations to the FDA on how to improve its review process, CDER Director Janet Woodcock said. McKinsey’s work includes a review of the length of time each ANDA has been in the FDA’s queue, as well as a determination of how many applications are awaiting action from the agency as opposed to a response from the sponsor, Woodcock said.
Washington Drug Letter
Washington Drug Letter
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