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Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

[ Price : $8.95]

U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for c...

Former CytoDyn CEO Sentenced to Prison

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A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about th...

FDA Cites Pine Pharma Over Sterility, Quality Control

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FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug ou...

FDA Reports Gains in Drug Inspection Program

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FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong perf...

Testing Deficiencies Cited at Asahi Kasei Finechem API Plant

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FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys ac...

FDA Highlights Expedited Pathways in Drug Approval Report

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FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...

Advocacy Groups Press Congress on Biosimilar Legislation

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Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-cal...

Sanofi Reports Positive Data for Atopic Dermatitis Drug

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Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-s...

FDA OKs Guardant360 CDx Companion Diagnostic

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FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant m...

Sato Pharmaceutical FDA-483 Out

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FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...