Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...

Predicting Bioequivalence During Generic Drug Formulation. Small variations in formulation can affect bioequivalence. However ...

On Friday, the Food and Drug Administration announced a new pilot prioritization program for the review of abbreviated new drug applications that aims to spur and reward investment in U.S. drug ...

Newman disagreed with the majority's narrow reading of the statute as focusing on bioequivalence testing by generic manufacturers, noting that the statute had been interpreted "expansively," and ...

Following successful small-animal trials that confirmed bioequivalence, BioNxt is now taking the final preclinical step to prepare its sublingual Cladribine formulation for human testing. The upcoming ...

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WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...

An internal US Food and Drug Administration (FDA) re-examination of previously submitted data has raised concerns that two generic medications used to treat attention ...

New facility includes 40 laboratories, genomics platforms and a bioequivalence center The center will test and certify locally produced medicines to meet regulatory standards Investment targets ...