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FDA Review on Amalgam Finds No Direct Safety Concern

[ Price : $8.95]

A new FDA literature review on dental amalgam safety finds no sufficient evidence of a relationship between clinically detectable ...

Fee for Pediatric Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a pediatric disease priority review voucher for fiscal...

Medical Countermeasure Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a material threat medical countermeasure priority revi...

Avanir Pharma Charged in Marketing Scheme

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The government charges Avanir Pharmaceuticals and four individuals for paying kickbacks to a physician to induce prescribing of it...

Guide on Patient-Focused Drug Development

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FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.

Guide on Device Software Policy Changes

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Federal Register notice: FDA makes available a final guidance on Changes to Existing Medical Software Policies Resulting From Sect...

FDA Cites Kowa Pharma DTC Video

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CDERs Office of Prescription Drug Promotion cites a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video mont...

Guide on Type A Medicated Articles

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Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form pro...

Clinical Decision Support Software Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Decision Support Software.

FDA Awards Contract to Advance Drug Safety System

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FDA awards a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safe...