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FDA Opens Q3C Solvent Impurities Web Page

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FDA opens a Web page with information on the International Conference on Harmonization Q3C maintenance procedures for revising the...

Enforce Clinical Trial Publication Law: Blogger

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Health Affairs blogger Stuart Buck calls on FDA to set aside a week to enforce fines on all clinical trials that are overdue for p...

Expedited ANDA Reviews Needed to Lower Drug Prices: AEI

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An American Enterprise Institute article says CDERs Office of Generic Drugs should fast-track ANDAs where high drug prices result ...

FDA Rejects Pfizer sNDA for Xeljanz

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FDA issues Pfizer a complete response letter denying approval of a supplemental NDA for Xeljanz (tofacitinib citrate) for treating...

Medline Industries Recalls Mislabeled Acetaminophen

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FDA says Medline Industries is recalling one lot of acetaminophen tablets, 500mg, uncoated compressed tablets because they are mis...

BMS, Five Prime Partner on Immunology/Oncology Therapies

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Bristol-Myers Squibb and Five Prime Therapeutics enter into an agreement for developing Five Primes colony stimulating factor 1 re...

FDA OKs Edwards Sapien for Aortic Valve-in Valve Procedures

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FDA approves an Edwards Lifesciences PMA for its Sapien XT transcatheter heart valve for aortic valve-in-valve procedures.

Panel Meets on BioMarin NDA for Duchenne Muscular Dystrophy

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/24 to discuss BioMarins ...

FDA Helped BI More Than Pradaxa Patients: Report

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Slamming FDAs objectivity in approving Pradaxa, the Project on Government Oversight makes 11 recommendations to help the agency fo...

Workshop on Emerging Infectious Diseases Trial Designs

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FDA plans an 11/9-10 public workshop on Clinical Trial Designs for Emerging Infectious Diseases in Bethesda, MD.