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Woodcock Plays Advisory Role at Patient Nonprofit

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Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advis...

PhRMA Changes for Data Committee Guide

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PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.

Alecensa OKd for ALK-Positive Lung Cancer

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FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplasti...

3rd Eugia FDA-483 This Year So Far

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FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra...

Its Official: Oncopeptides Pepaxto is Withdrawn

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FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has bee...

FDA Denies Generic Imodium Petition

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FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengt...

FDA Reports on Device Safety, Innovation

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CDRH releases reports on its commitment to medical device innovation and safety.

Boston Scientific Recalls Obsidio Embolic

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Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique f...

Sen. Cassidy Challenges FDA on CDS Oversight

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Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support soft...

Fresenius Recall Infusion Pump Softeware

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Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.