FDA announces new bioequivalence draft guidance for 31 active ingredients

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The Food and Drug Administration (FDA) have announced their most recent set of guidelines concerning the generic drug industry. The guidelines, released at the end of December, include guidance concerning thirty-one product-specific bioequivalence (BE) recommendations, and an additional thirteen revisions to their previous recommendations.

The FDA have been releasing such ongoing recommendations since 2010. They provide guidance on specific products, based on the designs of BE studies, in order to support the abbreviated new drug applications (ANDAs).

The guidances are currently only in draft format and have been issued in a manner consistent with the FDA’s good guidance practices regulation (21 CFR 10.115). Once they have been finalized, the guidances shall represent the FDA’s current thinking concerning those products specified above. Although the guidances don’t establish any rights for consumers and are in no way legally binding for the FDA or the public, they are never the less vital sources of information. Alternative approaches to those outlined by the FDA’s guidances are perfectly possible, providing they satisfy all requirements listed in the applicable regulations and statuses for the product or products in question.

 

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