U.S. Food and Drug Administration (01/22/2016)

The U.S. Food and Drug Administration (FDA) intends to publish several new and revised draft guidances involving biosimilars this year. Among the issues to be discussed are considerations in demonstrating interchangeability with a reference product, labeling for biosimilar products, and statistical approaches to evaluation of analytical similarity data to support a demonstration of biosimilarity. In addition, new or draft guidance will be issued on bioavailability and bioequivalence studies submitted in NDAs or INDs for orally administered drug products, adaptive design clinical trials for drugs and biologics, analysis of randomized controlled clinical trials to evaluate the safety of human drugs or biologic products, and nanomaterials in drug and biologic products.

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