FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances

Posted 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

FDA is announcing the availability of a new draft product-specific guidance for industry for drug products containing the following active ingredients:

BE

be2

FDA is seeking feedback on the drafts before it begins work on the final versions of product-specific guidance. FDA last issued a batch of such guidance documents in May.

Product-Specific Guidances for Generic Drug Development

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Categories: Generic drugs, Research and development, News, US, FDA

Tags: bioequivalence guidance, FDA draft guidance

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