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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 Alert on Boston Accolade Pacers Early Replacement

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FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need ...

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 Xcoverys Ensacove for Some Lung Cancers

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FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.

FDA Approves Humacytes Symvess

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FDA approves Humacytes Symvess for use with some extremity arterial injuries.

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.

Guide on Drug Batch Uniformity and Integrity

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FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...