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Avanir Pharma Charged in Marketing Scheme

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

Human Drugs

Guide on Patient-Focused Drug Development

FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.

Medical Devices

FDA Review on Amalgam Finds No Direct Safety Concern

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

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/27/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 9/27/2019.

Federal Register

Guide on Device Software Policy Changes

Federal Register notice: FDA makes available a final guidance on Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st...

Human Drugs

FDA Cites Kowa Pharma DTC Video

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

Federal Register

Guide on Type A Medicated Articles

Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form products and Type A med...

Federal Register

Clinical Decision Support Software Guide

Federal Register notice: FDA makes available a draft guidance entitled Clinical Decision Support Software.

Human Drugs

FDA Awards Contract to Advance Drug Safety System

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