Category Archives: Prescription and OTC Drugs

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FDA Issues Guidance on Manufacturing Drugs, APIs during COVID-19

FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them.  FDA is … Continue Reading

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active pharmaceutical ingredient (API) is made.  Acetris Health, LLC v. United States, 2018-2399, judgment of February 10, 2020.  In the Acetris case the API was made … Continue Reading
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