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AMA Wants Hormone Compound Oversight

[ Price : $8.95]

The AMA adopts a policy calling on FDA to take greater oversight over compounded hormone replacement drugs.

WLF Hits DDMAC on Mallinckrodt Letter

[ Price : $8.95]

Washington Legal Foundation objects to another DDMAC Warning Letter and the lack of any agency response to its complaints.

CDER Clin Pharm Deputy to Lead Biopharmaceutics

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CDER Division of Clinical Pharmacology 4 deputy director Arzu Selen accepts a new position as associate director for biopharmaceut...

Guide and Guidance Out on Drug Pedigrees

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Federal Register Notice: FDA releases a compliance policy guide and a guidance document on the pedigree requirements of the Prescr...

Panel to Discuss Sanofi-Aventis Ketek

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee meets 12/14-15 to discuss the benefit-to-risk considerations...

FDA Fast Track on Melanoma Drug

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FDA grants a fast track designation request from Synta Pharmaceuticals Corp. for STA-4783, indicated for treating metastatic melan...

Info on Device Fees for Small Businesses Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on device user fees and small business qualification to th...