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FDA OKs Merial sNADA for Calves

[ Price : $8.95]

Federal Register Final rule: FDA approves a supplemental NADA from Merial Ltd. For a medicated calf feed containing amprolium used...

Reviewers Question Genasense Clinical Significance

[ Price : $8.95]

FDA reviewers question whether Gentas leukemia therapy Genasense has shown any meaningful clinical significance.

FDA Panel to Review Fragmin Data Adequacy

[ Price : $8.95]

FDA plans to ask an advisory committee whether additional clinical studies are needed to assess a Pfizer-sought new indication for...

CGMP Violations at Wallach Surgical

[ Price : $8.95]

FDAs New England District Office warns Wallach Surgical Devices over CGMP violations at its manufacturing facility.

Renew Drug Approvals Like Driver Licenses?

[ Price : $8.95]

Hastings College of Law professor Marsha Cohen calls for a limited initial license for drugs to force companies to conduct post-ma...

Former FDA Head McClellan Resigns Medicare Post

[ Price : $8.95]

U.S. Medicare/Medicaid chief and former FDA commissioner Mark B. McClellan resigns effective early next month.

How an ASR is Marketed Determines 510(k) Exemption

[ Price : $8.95]

A new FDA guidance says that marketing a Class 1 510(k)-exempt analyte specific reagent in combination with other devices or tests...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Chien Ti Enterprise, Command Medical Products, and Wallach Surgical Devices.

FDA Ambush? Device Maker Faces $630,000 MDR Penalties

[ Price : $8.95]

Colorado device maker TMJ Implants alleges six years of bias and a sympathizer sees FDA ambush in an agency civil money penalties ...

FDA Clears Spirus Medical Enteroscopy System

[ Price : $8.95]

FDA clears a Spirus Medical 510(k) for its Endo-Ease Discovery SB, an upper gastrointestinal tract enteroscopy system.