FDA Related News

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include BBC Group, Lepu Medical Technology and Sanit Technologies.

Medical Devices

SpinTech MRI Software Cleared by FDA

FDA clears a SpinTech 510(k) for its Stage magnetic resonance imaging software.

Federal Register

Metastasis-Free Survival Endpoint Guide

Federal Register notice: FDA makes available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastas...

Federal Register

Guide on Near Infrared Analytical Procedures

Federal Register notice: FDA makes available a final guidance entitled Development and Submission of Near Infrared Analytical Procedures.

Human Drugs

Axsome Warns on NDA Review Delay

Axsome Therapeutics warns investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating major depressive diso...

FDA General

White House Shoots Down Rumored FDA Head Prospect

The White House denies that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in the running for the a...

Human Drugs

FDA, U of MD Workshop on Pediatric Trial Designs

FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation host a two-day workshop entitled Advancing the Developmen...

Human Drugs

NDA Filed for Urea Cycle Disorders Drug

Acer Therapeutics and Relief Therapeutics submit an NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders.

Intended Use Rule Clarifies Off-label Promotion Implications

Attorneys from Dechert pick apart FDAs recent intended use rule, which clarifies that the agency will not make a determination of a firms intent regar...

Human Drugs

Guide on Prostate Cancer Clinical Endpoints

FDA issues a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clini...