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FDA Wants More Risk Assessment in New Diabetes Drugs

[ Price : $8.95]

FDA says drug companies should immediately implement a new guidance calling for assessment of cardiovascular risk in all drugs bei...

FDA Paying Company to Predict Heart Events

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

Woodcock Predicts Slow, Strong Gains from Sentinel System

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

Guide on Companion Animal Anesthetic Products

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Federal Register Notice: FDA releases a draft guidance on anesthetics for companion animals.

Info on Blood Establishments Sent to OMB

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

Comments Sought on Export Requirements

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

Leavitt Discusses Partner in Speed Concept

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HHS secretary Mike Leavitt discusses next level of import safety plan third-party certification under FDAs Beyond our Borders in...

FDA, Defense, and Veterans Sign MOU

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Federal Register Notice: FDA provides a notice of a memorandum of understanding between the Office of the Assistant Secretary of D...

Will Light Cigarettes Case Show the Way on Preemption?

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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

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