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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.

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...

AseptiKits Marketing Adulterated, Misbranded Devices: FDA

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FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.

FDA Approves BESREMi Pen for Polycythemia Vera

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FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.

OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis

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A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of...