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Blood Products Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/14-15 to discuss dengue virus infection, murine leuke...

Comments Sought on Animal Drug User Fee Form

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the Animal Drug User Fee Act Cover Sheet.

Comments Sought on Medicated Feed CGMP

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on CGMPs for medicated feeds.

FDA Seeks Information on Sedation Products

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Federal Register Notice: FDA seeks information and encourages a public meeting to discuss issues on the clinical development and u...

Guidance on IVDs to Detect C. Difficile

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Federal Register Notice: FDA releases a draft guidance on establishing the performance characteristics of IVDs for detecting C. di...

Guidance on Drugs to Treat Pneumonia

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Federal Register Notice: FDA releases a draft guidance on developing drugs to treat hospital-acquired bacterial pneumonia and vent...

Guidance on Labeling Blood Lancets

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Federal Register Notice: FDA releases a guidance on labeling recommendations for blood lancets that the devices be used for only a...

Guidance on Impurities in Drug Products

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Federal Register Notice: FDA releases a guidance on ANDAs: Impurities in Drug Products.

Guidance on Antibacterial Drug Products

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Federal Register Notice: FDA releases a guidance, Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.

The Medicines Co. Agrees on Oritavancin Trials

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The Medicines Company reaches agreement with FDA under a Special Protocol Assessment on Phase 3 clinical trials for oritavancin in...