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Industry, FDA Agree on New Generic User Fees

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Stakeholders praise an agreement with FDA to extend the Generic Drug User Fee Act program for another five years.

FDA Fast Track for Cynapsus Parkinsons Diesease

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FDA grants Cynapsus Therapeutics a fast track designation for APL-130277, a product candidate for treating off episodes in patient...

Steps When a Clinical Trial Primary Outcome Fails

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Researchers list in the New England Journal of Medicine steps researchers can take to try to reduce having a clinical trial primar...

Integrity Agreement for Device Company in Kickback Scheme

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The HHS Office of Inspector posts a corporate integrity agreement between the government and Minneapolis-based Cardiovascular Syst...

Draft Elemental Impurities Guidance Needs Update: Glaxo

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Three stakeholders ask for clarifications in an FDA draft guidance on drug product elemental impurities.

Court Dismisses Amiodarone Suit Against Sandoz

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An Alabama federal court approves a Sandoz motion to dismiss claims against it alleging improper warnings about the risks of amiod...

Draft Guidance Allows Limited Generic Label Changes

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Attorney Bradley Davidsen says a new FDA draft guidance on safety updates to some generic drug labels raises hope that the agency ...

FDA Plans November Hearing on Off-label Communications

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FDA plans a two-day public hearing in November to obtain input on off-label communication by drug and medical device companies.

Regulations Prevent Petition Response: FDA

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FDA denies a petition asking it to place a clinical hold on an extracorporeal liver assist device reportedly being developed by Vi...

FDA Requires Warning of Opioid/Benzodiazepine Risks

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FDA requires labeling changes to many opioids and benzodiazepines warning about adverse risks of using them together.