FDA Related News

Human Drugs

Joint Panel Nixes Nektars Back Pain Drug

An FDA joint advisory committee votes 27 to 0 to not recommend approval of Nektar Therapeutics oxycodegol for back pain.

Human Drugs

FDA Updates List of Deemed BLAs

FDA updates the list of biological products that will be deemed to be BLAs on 3/23 to include chemically synthesized polypeptides.

McDermott Will & Emery FDA 2019 Review

A McDermott Will & Emery review of FDA activities in 2019 finds a slight decrease in overall enforcement activity as the agency continues focusing on ...

Human Drugs

Lannett Cocaine Nasal Anesthetic Approved

FDA approves a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), indicated for the introduction of local anesthesia in the mucou...

Human Drugs

FDA Still Questions Durects Posimir

FDA asks members of the Anesthetic and Analgesia Drug Products Advisory Committee to evaluate whether Durect has provided sufficient efficacy and safe...

FDA General

Machine Learning Increasingly Important to FDA

FDA staffers discuss the future role of machine learning in drug development and regulation.

Medical Devices

FDA Device Warning Letters May Increase: Keith

CDRH associate director Erin Keith says the Center will be issuing more Warning Letters now that staff are getting used to an internal reorganization.

Human Drugs

Expedited Review Doesnt Cut Development Time: Study

Harvard Medical School researchers say it is difficult to determine whether FDA expedited drug review and approval programs have actually incentivized...

Medical Devices

BioCardia Deflectable Guide Catheter Cleared

FDA clears a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell...

Medical Devices

Production and Process Controls Learning Module

CDRH consumer safety officer Vidya Gopal uses a Webcast to describe requirements in the production and process controls subsystem.