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Advisory Committee Backs BMS Diabetes Drug

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommends that the benefits of Bristol-Myers Squibbs diabetes drug dap...

FDA Wants More Data on Janssen Combo Diabetes Drug

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FDA issues Janssen a complete response letter on its NDA for a fixed-dose combination of canagliflozin and immediate-release metfo...

House Lawmakers Introduce Antibiotic Development Bill

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A bipartisan group of U.S. House lawmakers introduces the Antibiotic Development to Advance Patient Treatment Act of 2013.

John Taylor Leaving FDA Again

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FDA counselor to the commissioner and Global Regulatory Operations and Policy (GO) acting deputy commissioner John M. Taylor resig...

State AGs Want Zohydro ER Pulled or Reformulated

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Attorneys general from 29 states ask FDA to reconsider its approval of Zogenix Zohydro ER or order it to be reformulated to be abu...

Mallinckrodt Trial of Pain Drug Meets Endpoint

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Mallinckrodt says a Phase 3 efficacy trial of its investigational MNK-155 for managing moderate to severe acute pain has met its p...

Advisors Say Grastek is Safe and Effective

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Members of FDAs Allergenic Products Advisory Committee vote to recommend that Mercks Grastek is safe and effective for treating gr...

FDA Can Improve Medical Device Submission Process: Study

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Consultants Booz Allen Hamilton recommend four steps FDA could take to improve the medical device submission review process under ...

CDRH, ORA Compliance Improvement Pilot Program

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Additionally, FDA says it will expedite export certificate requests and prioritize device and pre-amendment determination requests...

FDA Panel Backs Stallergenes Allergy Drug

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FDAs Allergenic Products Advisory Committee votes 9 to 1 that available data support approval of a BLA for Oralair, indicated for ...