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Retiring FDA Office of Generic Drugs Director Uhl Cautions Industry that Haste Makes Waste in Application Approval Timelines

Jan 7th, 2019

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In offering some of the key learnings from her tenure as Director of FDA’s Office of Generic Drugs, Kathleen “Cook” Uhl is stressing that a “slow” and careful approach by sponsors during the ANDA submission and review process will actually result in faster approvals.

The message that a hurried approach in intersecting with the agency around applications is counterproductive and not in the interests of either sponsors or FDA resonated throughout her presentation on the “state of OGD” at the Association for Affordable Medicine’s “GRx&Biosims” Conference, held in Bethesda, Maryland in September.

Having announced that she would be retiring in February, Uhl’s presentation at the 2018 edition of the conference had a valedictory quality. She offered a broad view of the progress of the generics program and the challenges that remain to be dealt with – weaving in valuable insights on how industry can help assure that applications move through the approval process as expeditiously as possible.

The 2018 edition of the association’s “fall technical” conference continued to bring a broad swath of OGD and the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) management together with generics industry representatives to discuss the issues and developments impacting the review program and how it can be improved.  

 [The story continues for subscribers on p. 2.  Nonsubscribers can get information on individual IPQ subscriptions and organization-wide licenses by contacting Peter Blachly ([email protected]).]

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