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Some Generics May Get To Skip Fed Study Requirement If US FDA Research Pans Out

 
• By Derrick Gingery

Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.

Fed and fasting concept
The FDA is considering whether fasting and fed studies still should be required to show bioequivalence for most immediate-release generic drugs. • Source: Alamy

Generic drug sponsors soon could see the fed study removed as part of the US Food and Drug Administration’s requirement to demonstrate bioequivalence of some products, potentially saving money and time.

The FDA requirement for both in vivo fasting and fed studies for immediate-release generic bioequivalence is different from most other advanced regulators, which mandate only a fasting study. Research looking...

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