FDA publishes bio-equivalence guidance documents


SILVER SPRING, Md. — The Food and Drug Administration recently announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including Stendra, Belviq, Kalydeco and Brilinta, according to a blog published Monday by the Regulatory Affairs Professionals Society


According to the blog, the bioequivalence guidance documents released by FDA last week explain how each generic drug company can test its products to ensure approval. 


"Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for," noted blog author Alexander Gaffney.


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