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FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug

[ Price : $8.95]

FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a con...

FDA Accelerated Approvals Down This Year: AP

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An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over...

Pass VALID Act Now: Former Commissioners

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Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regula...

Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing

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FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-...

Selective Safety Data Collection Final Guidance

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Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Speci...

Contract Lab Valisure Relinquishes its Testing Prowess

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Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issu...

FDA Updates Endologix Endovascular Graft Safety

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FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal...

AG Hair Limited CGMP Issues

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FDA warns Coquitlam, Canada-based AG Hair Limited about CGMP violations in its production of hand sanitizer drugs for the U.S. mar...

CGMP Violations at Glenmark Pharmaceuticals

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FDA warns Glenmark Pharmaceuticals about CGMP violations in its production of finished drugs at a facility in Goa, India.

CGMP Violations in Kari Gran Inspection

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FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.