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FDA Paying Company to Predict Heart Events

[ Price : $8.95]

FDA says it has contracted with Entelos for computer-simulated analysis of cardiovascular adverse events.

Woodcock Predicts Slow, Strong Gains from Sentinel System

[ Price : $8.95]

CDER director Janet Woodcock tells stakeholders FDAs planned Sentinel system for accessing and sharing diverse health databases wi...

Guide on Companion Animal Anesthetic Products

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on anesthetics for companion animals.

Info on Blood Establishments Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on blood establishment registration and product listing to...

Comments Sought on Export Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection requirements imposed on firms exporting FDA-regulated produc...

Will Light Cigarettes Case Show the Way on Preemption?

[ Price : $8.95]

Attorney Kurt Karst says a Supreme Court ruling allowing smokers to file state deceptive advertising suits against cigarette compa...

No Registration for Most Bioequivalence Studies

[ Price : $8.95]

FDA says most bioequivalence studies are exempt from clinical trial registration requirements.

Quality System Violations at Contract Medical

[ Price : $8.95]

FDAs New England District Office says multiple Quality System violations were found in an inspection at Contract Medical Manufactu...

FDA Says Neuro Kinetics Markets Unapproved Devices

[ Price : $8.95]

FDA says Neuro Kinetics is marketing a number of vestibular analysis devices without marketing clearance or approval.

DDMAC: Xodol Sales Aid Widens Indication, Trims Risk

[ Price : $8.95]

DDMAC says a Victory Pharma professional sales aid for Xodol minimizes and omits risk information and broadens the indication.