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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Wilson Medicine Co.

Comments Reopened on Pediatric Device Development

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Federal Register notice: FDA reopens the comment the comment period provided in a 2/16 notice entitled Pediatric Medical Device De...

FDA Lifts Hold on Sarepta Gene Therapy Clinical Hold

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FDA lifts a clinical hold against Sarepta Therapeutics against the companys Duchenne muscular dystrophy micro-dystrophin gene ther...

Cook Medical 5mm Zilvr PTX Approved

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FDA approves Cook Medicals new 5 mm diameter version of Zilver PTX, the first 5 mm peripheral artery disease drug-eluting stent in...

Guide on Good Review Management Principles

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FDA releases a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and Biologics Lic...

ANDA Submission Content and Format Guide

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FDA releases a final guidance entitled ANDA Submissions Content and Format that details the information that should be provided i...

FDA Less Aggressive with Off-label Promotion: Woodcock

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CDER director Janet Woodcock acknowledges that the pendulum has swung away from aggressive FDA drug advertising and promotion enfo...

Patient Engagement Advisory Committee Meeting

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Federal Register notice: FDA announces an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations ...

CDER Priorities Include New Drugs Modernization

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CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent direct...

FDA Awards 12 Grants for Rare Disease Studies

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FDA awards 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical p...