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

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