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  • Regulatory NewsRegulatory News

    FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions

    The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent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