Transformation in Industry Practice Must Accompany FDA’s Generics Program Overhaul to Meet GDUFA Goals, OGD Stresses

A core message emerging from the presentations by FDA management at the GPhA/FDA Fall Technical Conference in Bethesda, MD in late October is that the transformation underway in the agency’s generic drug review program will need to be matched by an equivalent transformation in industry practice for the goals of the Generic Drug User Fee Act (GDUFA) to be achieved.

Providing a summary report on FDA’s progress in implementing GDUFA at the conclusion of the conference, Office of Generic Drugs (OGD) Acting Director Katherine “Cook” Uhl stressed the “game changing” nature of the act. Its implementation, she pointed out, is a “monumental task” that requires “a quantum leap” at the agency and in the industry to be successful.

The OGD leader highlighted the “huge” efforts underway at FDA to implement the changes needed to decrease Abbreviated New Drug Application (ANDA) approval timelines from 34 months to 10 months, and underscored the need for industry to transform its practices as well.

“I think the key take home message,” she said, “is that FDA and industry – the key word here is ‘and’ have to do this together.”

[An in-depth analysis of the impact that GDUFA has had on FDA’s generic drug review program and the opportunities and challenges that remain is provided for subscribers here.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]

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