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FDA Approves Expanded Xarelto Indication

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FDA approves an expanded indication for Janssens Xarelto to include patients with recent lower extremity revascularization under s...

7 Observations in Jubilant Generics FDA-483

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FDA released the FDA-483 with seven observations from an inspection at Indias Jubilant Generics drug manufacturing firm.

FDAers Boost Viral Clearance in Continuous Manufacturing

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FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therap...

Senators Want Info on FDA Relationship with McKinsey in Opioid Crisis

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A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the ...

CGMP Violation Found in Toyobo Inspection

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FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.

Product-specific Guidances for ANDAs

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Federal Register notice: FDA updates its listing of product-specific draft and revised draft guidances that provide recommendation...

Drug User Fee Reauthorization Meeting

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Federal Register notice: FDA announces a 9/28 virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Ac...

Argyle UVC Insertion Tray Class 1 Recall

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Cardinal Health recalls its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalp...

Guide on ANDA Bioequivalence Studies

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Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submi...

Industry Seeks Changes to Cancer Trials PROs Guidance

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In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patien...