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Guidance on Active Control Animal Drug Studies

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for...

Panel to Discuss Vandas NDA for Sleep-Wake Disorder

[ Price : $8.95]

Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/14 to discuss a Vanda Ph...

Public Meeting on Meta-Analyses to Assess Trial Safety

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Federal Register Notice: FDA plans a public meeting 11/25 to obtain input on using meta-analyses of randomized controlled clinical...

Panel to Discuss Genzyme sBLA for MS

[ Price : $8.95]

Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/13 to discuss a Genzyme ...

FDA Clears New Hospira Infusion System

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FDA clears a Hospira 510(k) for the Sapphire infusion system.

FDA, Repros to Talk About Androxal Studies

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FDA tells Repros to request a teleconference to talk about clinical trials of its Androxal testosterone drug.

Codman and Shurtleff Pump Recall Class 1

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FDA says a recall of Codman and Shurtleff MedStream infusion pumps is Class 1.

FDA Completing Phase-out of CFC Inhalers

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FDA says its phase-out of medical inhalers with chlorofluorocarbon propellants will be completed by 12/31.

Correction on Fibromyalgia Meeting Comments

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Federal Register Notice: FDA corrects dates for submission of comments from a 9/23 Federal Register notice on a public meeting on ...

Panel to Discuss BioMarin BLA for Vimizim

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/19 to discuss a BioMarin BLA for ...