The Generic Drug User Fee Act of 2012 (GDUFA) established a new regulatory science initiative to support the generic drug program. This presentation will discuss FDA’s consideration of active ingredient “sameness” for generic drug products containing complex drug substances, and the efforts that the Office of Generic Drugs is undertaking to support advances in analytical methods under GDUFA regulatory science.

Regulatory science under the Generic Drug User Fee Act of 2012 (GDUFA), including FDA’s consideration of complex drug substances and innovative analytical method development

251st National Meeting (2016)

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