FDA Related News

Medical Devices

Device PMA Advisory Meetings Disappearing: Attorneys

Attorneys Jeffrey Gibbs and McKenzie Cato say that FDA advisory committee meetings to review product applications may become a thing of the past.

Human Drugs

Clovis sNDA for Rubraca Accepted for Review

FDA accepts for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in certain dult patien...

Medical Devices

Neovasc PMA for Reducer Accepted for Review

FDA accepts for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina.

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.