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QS Violations in Dongguan Rainbow Tech Inspection

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FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing o...

Report on Ways to Cut Reliance on Foreign Drugs

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The Senate Special Committee on Aging releases a report with six recommendations for reducing the use of foreign-made drugs for se...

Makary Details DTC Enforcement Crackdown on Podcast

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FDA commissioner Marty Makary addresses during a podcast the agencys significant shift in enforcement policy directed at pha...

FDA Still Finding Issues at Nephron Pharmaceuticals

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A South Carolina newspaper reports that the latest FDA inspection at Nephron Pharmaceuticals found the company still has significa...

Moderna Quits CMV Vaccine After Phase 3 Failure

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Moderna stops the development of its congenital cytomegalovirus vaccine after it failed to meet the primary endpoint in a large Ph...

3rd Patient-Focused Drug Development Guidance

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FDA publishes the third in a series of guidances on aspects of collecting patient experience data to be used in medical product de...

sBLA for PadcevKeytruda Combo in Bladder Cancer

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FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...

Fast Track for Myosin Glioblastoma Drug

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FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.

Major Staff Losses at CDER and CBER Amid Shake-up

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FDA releases hiring data showing steep declines in staffing at CDER and CBER.

CGMP Violations Seen in BRS Services Inspection

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FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.