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Panel Sees Lipid Subfraction Value

[ Price : $8.95]

FDAs Clinical Chemistry and Clinical Toxicology Devices Panel says lipid subfraction assays may have some value in assessing patie...

Lilly Evista NDA for Breast Cancer

[ Price : $8.95]

Eli Lilly files an NDA to FDA for Evista seeking approval to use the drug in postmenopausal women to reduce risk of invasive breas...

Supplement Reporting Bill Passes Senate

[ Price : $8.95]

The Council for Responsible Nutrition urges the House to quickly approve Senate-backed legislation requiring supplement and OTC dr...

FDA Boosts Pay of Field Leaders

[ Price : $8.95]

In our latest analysis of FDA employee compensation, we find the pay of top field leaders increased in 2005, top earners exceeded ...

FDA Wants Info on Sparlon Trial Event

[ Price : $8.95]

FDA wants more information on an adverse event from a Cephalon modafinil trial.

Von Eschenbach Confirmed After Frist Move

[ Price : $8.95]

The U.S. Senate votes 80-11 to confirm Andrew von Eschenbach as FDAs next commissioner, following a successful cloture move by maj...

Medarex Ipilimumab on Fast Track

[ Price : $8.95]

FDA gives Medarex ipilimumab fast track designation for two indications.

Ela Medical PMA on Ovatio CRT-D

[ Price : $8.95]

Ela Medical submits a PMA for its Ovatio cardiac resynchronization therapy defibrillator.

Duplicate Notice on Device Small Business Withdrawn

[ Price : $8.95]

Federal Register Notice: FDA withdraws a duplicate 60-day notice on device small business certification forms.

FDA Removes Essential Use for MDI Ingredients

[ Price : $8.95]

Federal Register Direct final rule/proposed rule: FDA removes the essential use designations for seven ingredients used in oral pr...