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New FDA recommendations for bioequivalency studies

New recommendations for 35 specific ANDA products, plus 12 revisions

On 27 January 2016, the FDA updated their Bioequivalence (BE) Recommendations for specific products. Under this link you can find BE guidances for close to 1400 products, sorted by active ingredient. Highlighted are those new and revised BE guidances since December 31, 2015.

The site also refers to the overall 2013 draft guidance “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” which you can access a here .

BE studies are vital in order to show that a generic product is having the same performance as the original reference product. Showing bioequivalency is necessary in order to receive market approval for an ANDA (Abbreviated New Drug Application). ANDA is the FDA term for a generic product.

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