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FDA Outlines Path for Generic Advair Products

[ Price : $8.95]

FDA releases a draft guidance that outlines a path for generic companies to market copies of GlaxoSmithKlines Advair (fluticasone ...

Q&A Guidance on Generic Drug User Fees

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Federal Register Notice: FDA releases a draft guidance: Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision ...

Drug Failures Vary by Study Phase, Drug Class: Study

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A Tufts Center for the Study of Drug Development Impact Report says causes of drug failures in clinical trial vary according to tr...

FDA Rejects Requested Opioid Changes

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FDA rejects several requests from Physicians for Responsible Opioid Prescribing for changes to opioid labeling.

Comments Sought on Device Fellowship Program

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Federal Register Notice: FDA seeks comments on the value of CDRHs application form for participation in the Medical Device Fellows...

BE Guidance on Advair Generics

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Federal Register Notice: FDA releases a draft guidance: entitled Bioequivalence Recommendations for Fluticasone Propionate; Salmet...

FDA Revises GDUFA Guidance

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FDA adds questions and answers to its guidance on GDUFA implementation.

Change Control is FDA Focus in Quality Agreements: Attorney

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A food and drug lawyer says NDA sponsors who use contract manufacturing organizations should define change control in their qualit...

Biodel Claims Product Comparability to Lillys Humalog

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Biodel reports positive Phase 2 clinical trial data for BIOD-123, an investigational ultra-rapid-acting mealtime insulin being eva...

FDA Accepts Merck NDA for Fertility Drug

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FDA accepts for review a Merck NDA for its investigational fertility treatment, corifollitropin alfa.