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New Bioequivalence Standards for Generics Needed: Group

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American Enterprise Institute researchers say FDA needs greater transparency on how generic drugs are found to be bioequivalent an...

Since Our Last Issue ...

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Industry news you may have missed since our last issue.

Boston Scientific Recalls Chariot Guiding Sheath

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Boston Scientific recalls its Chariot Guiding Sheath due to the risk of shaft separation.

Time for an FDA Makeover, Professor Asserts

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Independent Institute Research fellow and University of Tampa assistant professor Abigail R. Hall says its time to rethink FDAs ro...

FDA Approves New Indications for Infuse Bone Graft

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FDA approves Medtronics Infuse Bone Graft for three additional spine surgery indications for use with certain spine implants.

FDA Colluded with Industry to Write Cures Act: Group

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Public Citizen condemns senior FDA officials for colluding with the Advanced Medical Technology Association to help write legislat...

Accelerated Approval for Genentech Cancer Drug

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FDA grants an accelerated approval for a Genentech NDA for Alecensa (alectinib) and its use in treating patients with metastatic A...

FDA Approves Wellstats Chemo Overdose Drug

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FDA approves a Wellstat Therapeutics NDA for Vistogard (uridine triacetate) for the emergency treatment of adults and children who...

FDA, OHRP Extend Comment Period on IRB Guidance

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FDA and HHS Office for Human Research Protections extend by 30 days the comment period for a joint draft guidance entitled Minutes...

Some Baclofen API May be Contaminated: FDA

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FDA cautions of potential serious risks associated with contaminated baclofen API manufactured