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Astellas Recalls Lots of Prograf and Astagraf

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FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.

FDA Wants Labeling Changes for Buprenorphine

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FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...

Bhargava Phytolab CGMP Violations

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FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....

QS, MDR Violations at Rontis Hellas in Greece

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FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon cathet...

FDA Approves BMS Opdivo Qvantig Injection

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FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.

Global Unique Device ID Database Guidance

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FDA publishes an updated Global Unique Device Identification Database guidance.

Axsome Plans Alzheimers NDA on Mixed Data

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Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating A...

Exclude Liraglutide from Compounding: Novo Nordisk

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Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compo...

Mylan 6-Item Form FDA-483 Posted

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FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing...

FDA Approves Checkpoints Unloxcyt

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FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.