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CGMP Violations at Canadas Vegewax Candleworx

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FDA warns Concord, Ontario, Canada-based Vegewax Candleworx about CGMP violations in its production of finished drugs.

Smiths Medical Recalls Venous Access System

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Smiths Medical recalls its ProPort Plastic Venous Access System because the devices plastic port housing and port reservoir may se...

2 ICH Guidelines Advance

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The International Council for Harmonization says the M11 and M13B guidelines have advanced to the second public consultation.

Device Consensus Standards Publication

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Federal Register notice: FDA updates its publication on modifications to the list of recognized consensus standards for use in dev...

Keytruda Full Approval for Gastroesophageal Cancer

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FDA awards Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for th...

bioMrieux Gets Vitek Compact Pro Cleared

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FDA clears a bioMrieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification and antibiotic susc...

Sarepta Reports Death Linked to Elevidys

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Sarepta says a young man with Duchenne muscular dystrophy being treated with Elevidys has died from acute liver failure.

Balance Drug Approval Flexibility, Evidence: Study

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Harvard University researchers say drug regulators must balance incentives for expedited approvals of first-in-class drugs with ev...

Nurix Gets Orphan Status for Bexobrutideg

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FDA grants Nurix Therapeutics an orphan drug designation for bexobrutideg and its use in treating Waldenstrm macroglobulinemia.

Physician-Investigator Objectionable Conditions

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FDA warns Adventura, FL-based Mehran Bahrami about objectionable conditions in his conduct of three clinical investigations.