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 ...

The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...

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 ...

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the ...

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

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 ...

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 ...

PRINCETON, N.J.--(BUSINESS WIRE)--Certara ® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp ® ...

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 ...