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FDA OKs Kips Bay IDE for eSVS Mesh

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FDA grants approval with conditions to Kips Bay Medical for an Investigational Device Exemption to include four U.S. study sites o...

Incomplete Process Validation Most Common Biologics Problem

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CBERs Nicole Trudel tells the RAPS annual meeting that process validation issues are the most common she finds in biologics pre-li...

FDA Confirms Aricept 23 Approval

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FDA denies a Public Citizen petition asking that it withdraw Eisais Aricept 23 from the market.

Workshop on Outcome Metrics for Orthopedic Device Science

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Federal Register Notice: FDA plans a public workshop 11/27-28: Minimum Clinically Important Difference: An Outcome Metric in Ortho...

Workshop on Burkholderia Issues

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Federal Register Notice: FDA plans the public workshop 11/29-30 on exploring current issues and identifying regulatory science gap...

Boehringer Recalls 1 Pradaxa Lot Due to Packaging Defect

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Boehringer Ingelheim Pharmaceuticals recalls one lot of Pradaxa (dabigatran etexilate mesylate) 75mg due to a potential packaging ...

Arisaph Reports Positive Safety Results for Niacin Analog

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Arisaph Pharmaceuticals reports positive safety results from two trials of its niacin analog, ARI-3037MO in healthy volunteers.

Few Pediatric Trials Moving Overseas: FDA Study

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A study by FDAs Office of Pediatric Therapeutics finds that the U.S. continues to host the vast majority of pediatric clinical tri...

FDA Fast Track for Nektar Breast Cancer Therapy

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FDA designates fast track status for Nektar Therapeutics NKTR-102 (etirinotecan pegol) for treating patients with locally recurren...

Composition of CDER Exclusivity Board Unclear

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Attorney Kurt Karst says CDERs Exclusivity Board has been functioning for several months although the names of members have not be...