FDA Related News

Human Drugs

Advisory Panel Votes Down Alkermes Depression Drug

Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 21 to 2 that the benefit-r...

Medical Devices

Guide on Unique Device ID Compliance Date Deferrments

FDA posts a guidance on Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices...

Federal Register

Draft Guide on Hepatitis B Drugs

Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.

Federal Register

Workshop on Hemophilia Product Development

Federal Register notice: FDA announces a 12/6 public workshop entitled Product Development in Hemophilia.

Human Drugs

FDA Approves Controversial Pain Drug

FDA approves an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute ...

Medical Devices

2 Devices Cleared for Parathyroid Tissue Detection

FDA permits the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectom...

Human Drugs

Hepatitis B Drug Development Guidance Out

FDA issues a draft guidance to assist sponsors develop drugs and biologics to treat chronic hepatitis B viral infections.

FDA Warns About Some Genetic Test Predictions

FDA warns against using results from many genetic tests to predict how a patient will respond to a specific medication.

Federal Register

Class 2 for Meprobamate Test System

Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls).

Medical Devices

De Novo Marketing for Pharmacogenetic Reports

FDA permits the de novo marketing of 23andMes Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for providing information a...