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CGMP Violations at Outin Futures

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FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.

Noxafil Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not wit...

IntraBio Wins Priority Voucher for Aqneursa Approval

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Federal Register notice: FDA issues IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacety...

14 Observations in Qualgen FDA-483

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FDA releases the form FDA-483 with 14 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing faci...

FDA Clears AI-Interpreting Echocardiography Software

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FDA clears an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography.

Jazz Plans sNDA for Zepzelca in Lung Cancer

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Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical tria...

CDER, CBER Working on START Trial Support Program

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CDER director Patrizia Cavazzoni says the Center worked with CBER to launch in 2023 the START program, providing selected particip...

CDER Drug Shortage Management Process

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FDA posts a consumer-focused explanation of how CDER determines and manages drug shortages.

CDRH Pilots Trial Participation Snapshots

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CDRH pilots medical device trial participation snapshots to provide key information about clinical trials that supported their app...

IDE for Implantable Underactive Bladder Implant

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FDA gives the green light to Iota Biosciences for an early feasibility study of its investigational implantable device in underact...