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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 ...

Global Unique Device ID Database Guidance

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FDA publishes an updated Global Unique Device Identification Database guidance.

FDA Approves Checkpoints Unloxcyt

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

FDA Approves Novo Hemophilia Prophylaxis Drug

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FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.

New Sleep Apnea Indication for Lillys Zepbound

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FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.

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.

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.

CGMP Violations in Micro Orgo Chem Inspection

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FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.