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ORA Reorgs Impact on Drug Inspections: Cavazzoni

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CDER director Patrizia Cavazzoni provides an update on the reorganization of FDAs Office of Regulatory Affairs (ORA) regarding ins...

Breakthrough Status for Myotonic Dystrophy Therapy

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FDA grants Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran and its use in treating myotonic dyst...

FDA on Ongoing Getinge Device Concerns

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FDA reminds healthcare providers and facilities about the agencys continuing safety and quality concerns with some Getinge/Maquet ...

FDA, EPA, USDA Biotechnology Plan

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FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Execut...

FDA Grants, Denies Kaiser 2009 REMS Petition

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FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation ...

Orphan Status for Mabwell Esophageal Cancer Drug

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FDA grants China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for tre...

Bioresearch Monitoring Violations at DBC Research

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FDA warns Dr. Kevin Bender, doing business as DBC Research in Tamarac, FL, about violations in his conduct of clinical trials.

Endo Paying $1.5 Billion Fines, Forfeitures

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Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into inters...

LDT Final Rule Legal Challenges Likely: Attorneys

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Six Hogan Lovells attorneys comprehensively analyze the new FDA final rule on laboratory-developed tests and predict industry stak...

Hearing to Grill FDA Center Directors

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The House Energy and Commerce Committee announces a 5/22 hearing titled Check Up: Examining FDA Regulation of Drugs, Biologics, an...