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European Regulators Looking at Califf Trial: POGO

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The Project on Government Oversight says a European drug regulator is looking into reports that a clinical trial for Janssens Xare...

Reflect 1st Amendment in Intended Use: WLF

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Washington Legal Foundation says FDAs proposed revised regulations on intended uses of drugs and medical devices should reflect cu...

FDA, Guided Therapeutics Agree on LuViva PMA Path

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Guided Therapeutics says it has reached a general agreement with FDA on a process to collect data for a PMA submission for its LuV...

AbbVie NDA Filed for Once-daily Viekira Pak

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AbbVie files an NDA for a once-daily, fixed-dose formulation of the components of Viekira Pak (ombitasvir, paritaprevir, and riton...

Teva Adds Heptares Migraine Drug to its IND Portfolio

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Teva Pharmaceutical Industries enters into a licensing and drug-discovery agreement with Heptares Therapeutics to develop small-mo...

FDA Inconsistent in Drug Surrogate Evaluation: Study

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A study reported in BMJ Open says that FDA is inconsistent in its approach to the challenge of evaluating surrogate outcomes in so...

Guidance on Veterinary Feed Directive Common Format

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Veterinary Feed Directive Common Format Qu...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites NVision Laser Eye Centers, One Way Drug, LLC dba Partell Specialty Pharmacy, and...

Lesser-known Preemption Arguments

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Attorney James Beck reviews three court decisions based on lesser-known preemption arguments.

QS Violations at WalkMed Infusion

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FDAs Denver District Office warns WalkMed Infusion about Quality System and other violations in its manufacturing of infusion pump...