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Chinese Drug Firm Refuses FDA Record Request

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FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter d...

CBER SOPP on Implementing, Managing REMS

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CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.

FDA Novel Drug Approvals Remain Steady in 2026 First Half

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FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consist...

Complete Response on Liver Imaging Agent

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FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.

OIG Backs Manufacturer-Sponsored Patient Tests

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Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party la...

Former CDC Official Alleges Political Interference In Vaccine Policy

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During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no l...

Insufficient Data on 7 Peptides for Potential Compounding Use: FDA

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FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven pep...

BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

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FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in pl...

FDA OKs Casgevy for Younger Children

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FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.

Quality System, Other Violations at 3B Medical

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FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported f...