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FDA Corrects Notice on Critical Path Workshop

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Federal Register Notice: FDA corrects Web links for registration for a scientific workshop co-sponsored by FDA and the Coalition A...

FDA Expands Warning on Drugs in Becton-Dickinson Syringes

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FDA expands an alert on compounded or repackaged drugs stored in Becton-Dickinson syringes to additional sizes because interaction...

FDA Approves Tandem Diabetes PMA for Insulin Pump

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FDA approves a Tandem Diabetes Care PMA for the t:slim G4 Insulin Pump, a touch-screen pump with continuous glucose monitoring int...

AGA Says Guidance Will Catalyze Drug Development

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The American Gastroenterological Association praises FDA for its draft guidance on clinical evaluation of drugs for treating gastr...

ICH Guide on Elemental Impurities Released

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FDA releases an International Conference on Harmonization guidance on Q3D Elemental Impurities.

Patent Reform Threatens Innovation: Greenwood

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BIO president Jim Greenwood calls on Congress to change a patent dispute process that is hurting biotech companies.

FDA Sends Info on Clinical Trial Guidance to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance for...

Glucagon Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Glucagon for injection equivalent to 1 mg base/vial and equivalent 10 mg base/vial wa...

Guidance on Endocrine-Related Drug Toxicity

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Federal Register Notice: FDA releases a guidance: Nonclinical Evaluation of Endocrine-Related Drug Toxicity.

Despite Protests, FDA Hangs Tough on LASIK

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Despite continued agitation by patient activists claiming injuries from LASIK vision correction procedures, FDA says it has not fo...