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FDA-483 Posted on Hybrid Pharma Inspection

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FDA posts a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspec...

Comments Sought on Powered Stretcher Exemption

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Federal Register notice: FDA seeks comments on a petition requesting exemption from the premarket notification requirements for po...

Impax Ursodiol Capsules Withdrawn Over BE Data

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Federal Register notice: FDA withdraws approval of an Impax ANDA for ursodiol capsules (XXX INSERT XXX)USP, 300 mg, due to agency ...

Gottlieb Added to FasterCures Board

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Former FDA Commissioner Scott Gottlieb joins FasterCures advisory board.

FDA Clears Zimmer JuggerStitch Meniscal Repair

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FDA clears a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device.

Guide on Special 510(k) Program

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Federal Register notice: FDA makes available a final guidance entitled The Special 510(k) Program.

Carcinogen NDMA Now Spreads to Heartburn Drugs

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An FDA safety alert says that an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has n...

FDA Biosimilar Bioanalytical Best Practices Coming

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FDA says it will develop bioanalytical best practices for biosimilar biological product development.

Warning on CDK 4/6 Inhibitors Lung Condition

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FDA warns that Pfizers Ibrance (palbociclib), Novartis Kisqali (ribociclib), and Eli Lillys Verzenio (abemaciclib) used to treat s...

KRS Global Recalls Drugs Over Sterility

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KRS Global Biotechnology recalls all lots of unexpired human and animal drugs due to sterility concerns.