Headlines

Latest FDA News and Information

FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic

The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to... read more

FDA approves Ofev to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

FDA approves Esbriet to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Federal judge approves FDA consent decree with Ascend Laboratories

A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey... read more

Food and Drug Adminstration (FDA): CDRHNew

LASIK Quality of Life Collaboration Project

In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential... read more

Medical Device Webinars and Stakeholder Calls

This page provides information on upcoming and past webinars held by the Center for Devices and Radiological Health (CDRH). Please see CDRH Learn for additional training modules.

Presentations posted for October 8-9, 2014 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Presentations posted for October 8-9, 2014 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Class I Medical Device Recall: CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure (Added Affected Lot Numbers)

The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg). They are used in hospitals, during... read more

What's New: Vaccines, Blood & Biologics RSS Feed

Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the... read more

Jobs at the Center for Biologics Evaluation and Research (CBER)

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

Complete List of Currently Approved NDA and ANDA Application Submissions

Information updated through September 30, 2014

Complete List of Currently Approved Premarket Approvals (PMAs)

Information updated through September 30, 2014

Subscribe!

Enter your e-mail address to get information about upcoming conferences from FDAinfo.com!


Newsletter preference:
HTML Text AOL