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Marks OK with Some Gene Accelerated Approval Mistakes

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CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.

Latest Implied Preemption Case Reviewed

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Three Winston & Strawn attorneys say that by declining to hear an appeal, the Supreme Court has affirmed that some state law claim...

Multiple Violations in Bioptimal Inspection

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FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters....

CDRH Product Evaluation/Quality Office Modified

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Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structur...

FDA OKs TE Code for Paclitaxel Suspension

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FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply fo...

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...

FDA OKs Breakthrough Colorectal Cancer Test

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FDA approves Geneoscopys colorectal cancer stool-based screening test ColoSense for those aged 45 years and older with an average ...