FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions

Thursday, June 16, 2016

Source: RAPS

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

The new draft documents focus on what types of bioequivalence (BE) studies may need to be conducted to obtain abbreviated new drug application (ANDA) approval. Each document also contains information on what analytes should be measured, what dissolution test methods should be used and sampling times.

The latest bunch of drafts and revisions follows FDA’s release in January of product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) linked to new generics and revised recommendations for 11 APIs, as well as the release of 38 draft guidances for APIs in April.

- See more at: http://www.raps.org/Regulatory-Focus/News/2016/06/16/25149/FDA-Offers-New-Draft-Guidance-on-Bioequivalence-Studies-for-19-Generics-19-Revisions/#sthash.tYKY6huh.dpuf

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