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House Committees Probe Biogens Alzheimers Approval

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Two House committees request documents from Biogen about its controversial Alzheimers drug approval.

FDA Raises Roxadustat Safety Concerns

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An FDA briefing document asks members of the Cardiovascular and Renal Drugs Advisory Committee to consider potential safety risks ...

CGMP, Other Issues Found at Guangzhou Minghui Cosmetics

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FDA says hand sanitizer produced by Chinas Guangzhou Minghui Cosmetics Co. is an unapproved new drug that is adulterated and misbr...

CURE ID Automating Data Collection

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CDERs Heather Stone describes improvements made to CURE ID to make it possible to track repurposed Covid-19 drugs more easily.

Industry Outlines Overall MDUFA 5 Proposal

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Just-released minutes describe industrys overall proposal for the MDUFA 5 agreement.

Variable Clinical Pharmacology Studies for Peptides Needed: Merck

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Merck calls on FDA to consider using a variety of methods to assess clinical pharmacology for peptides.

FDA Accepts Invivos 1st Neuro-Spinal Scaffold HDE Module

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FDA accepts the first HDE module submitted by Invivo for its Neuro-Spinal Scaffold implant.

Halodine Marketing Covid-19 Unapproved New Drugs: FDA

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FDA warns Halodine it is marketing unapproved and misbranded non-alcohol-based antiseptic products for Covid-19.

FDA, J&J Mull Guillain-Barré Warning on Vaccine

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Johnson & Johnson discusses with FDA and other regulators rare cases of Guillain-Barré syndrome that have been reported foll...

Q & A Guide on Cell/Tissue Product Enforcement

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FDA posts a guidance that answers common questions about the end of the compliance and enforcement policy for certain human cells,...