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FDA May Not be Ready for LDT Rule: Attorney

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Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests wit...

Oncology Drug Dose Optimization Often Deferred: Analysis

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More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (o...

FDA Approves Next-Gen Lap-Band

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FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for we...

First Psychedelic NDA Filing Claimed for PTSD Therapy

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MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine ca...

Phathom Pharma Files NDA for Heartburn

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FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with ...

Guide on DTC Quantitative Efficacy/Risk Info

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FDA issues a revised final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Pro...

Device CEO Pleads Guilty in Covid Test Scheme

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Former Decision Diagnostics CEO Keith Berman (Westlake Village, CA) pleads guilty to securities fraud, wire fraud, and obstruction...

FDA Requiring Less Burdensome Isotretinoin REMS

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FDA tells isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy to minimize the b...

NDA Resubmission on Hypoparathyroidism Accepted

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FDA accepts an Ascendis Pharma NDA resubmission for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism...

InvaGen Pharma Recalls Vigabatrin Lot

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Ciplas InvaGen Pharmaceuticals unit recalls one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues.