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Petition Evidence Against Boston Scientific Mesh

[ Price : $8.95]

A citizen petition supplement provides what it says is evidence that Boston Scientific is not using genuine Marlex resin in its tr...

Lachman Identifies 3 Big Industry Issues

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Lachman Consultants describes three correspondence)issues with FDA that it says are driving drug companies crazy.

FDA Seeks Extension on CDRH Pre-Submission Program

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Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to CDRHs...

FDA Clears Expanded Indication for Avinger PAD System

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FDA clears an Avinger 510(k) for the Pantheris Lumivascular atherectomy system for use in Peripheral Artery Disease patients for t...

Ways to Improve Drug Labels: Pitts

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Former FDAer Peter Pitts says that drug companies have information that could improve patients health and FDA should find ways to ...

Akorn Pharmaceuticals Inspection Observations

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An FDA-483 details inspection observations from Akorn Pharmaceuticals.

Jenkins Slams Sareptas Development of Duchenne Drug

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CDER Office of New Drugs director John Jenkins publicly criticizes last months controversial decision of his boss, Center director...

Attorney Praises 3rd Circuit Sheller Decision

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Attorney James Beck praises an appeals court decision that a plaintiff law firm does not have standing to sue FDA to compel the ag...

Appreciation for FDA Next-gen Sequencing Guidances

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Five stakeholder groups offer praise and suggestions to improve an FDA draft guidance on use of public databases to support clinic...

Physician Group Cant Sue FDA Over Drug OK

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The 9th Circuit appeals court upholds a lower court decision that Physicians for Integrity in Medical Research has no standing to ...