US FDA issues new BE guidelines for 50 APIs

Related tags Food and drug administration

FDA publishes bioequivalnce guidelines for APIs
The US FDA has issued draft bioequivalence guidelines for nearly 50 active pharmaceutical ingredients (API) in a notice in the Federal Register.

The new draft guidelines​ – which cover a wide range of ingredients (see fact box) – are intended as a guide for generic drugmakers designing bioequivalence (BE) studies to support abbreviated new drug application (ANDA) submissions.

The Food and Drug Administration (FDA) has been publishing product specific BE guidelines since 2010​ when it concluded that making such information available, rather than requiring that drugmakers request it, was more efficient.

The new set of guidelines is accompanied by several revised versions of previously published BE recommendations (section III).

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