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FDA’s Generics Office Overcomes Tough Challenges to Meet Year 3 GDUFA Goals, OGD’s Uhl Reports at GPhA Conference

Jan 26th, 2016

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A significant increase in controlled correspondences, easily correctable deficiencies, and information requests, along with a major reorganization, were among the tough challenges that the Office of Generic Drugs (OGD) overcame to meet the Year 3 goals of the Generic Drug User Fee Act (GDUFA) – the first year that goals came into play.

Developing the interface with the newly formed Office of Pharmaceutical Quality (OPQ) and a hiring and training blitz that brought more than 1,000 new staff members into OGD were among the other hurdles that the office faced in pursuit of the GDUFA goals in place for FDA’s fiscal year (FY) 2015, which ended September 30.

At the GPhA/FDA Fall Technical Conference in Bethesda, Maryland in early November, OGD Director Katherine “Cook” Uhl commented that GDUFA implementation has required “a deep foundational restructuring of everything related to the generic drug review program.  We had to build an entirely new infrastructure. We had to not only define our business processes, but improve them and create efficiencies along the way.”

In her presentation, Uhl discussed the challenges the generics office faced in GDUFA Year 3 and its achievements, and what her office will be doing to further enhance the review process and meet the Year 4 and 5 targets.

She highlighted how GDUFA creates more predictability for industry and what actions the agency and industry need to take to further the goal.

The OGD director then delved into her office’s productivity and output – providing the data through GDUFA Year 3 on ANDA/supplement approvals, controlled correspondence, complete response letters, and GDUFA backlog, and the progress on product-specific guidances.   

Uhl concluded her talk with “helpful hints” on “controlling your destiny,” which included a review of the common deficiencies the agency is seeing related to application review, and how they can be avoided. She addressed issues involving the cover letter, the point of contact, the facility establishment identifier (FEI), bioequivalence, clinical data, labeling and controlled correspondence.

 [The story continues on p. 2. Along with the in-depth review of Uhl’s presentation, included is an outline of the range of issues that were addressed during the course of the GPhA conference as a whole. Non-subscribers can get information on IPQ subscriptions/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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