Latest FDA News and Information

First vaccine approved by FDA to prevent serogroup B Meningococcal disease

The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis... read more

FDA approves new treatment for rare form of hemophilia

The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [... read more

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).

Food and Drug Adminstration (FDA): CDRHNew

Presentations Added to 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

Recorded Webinar and Transcript added for the Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance Webinar (10/23/14)

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.

FDA Voice Blog: FDA as part of a coordinated global response on Ebola

The tragic Ebola epidemic is an extraordinary global public health crisis, and FDA is taking extraordinary steps to be proactive and flexible in our response ? whether it?s providing advice... read more

FDA Voice Blog: FDA Encourages Development of Devices for Patients with Disabilities

For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain,... read more

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October 29, 2014 Approval Letter - TRUMENBA

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

Flebogamma DIF 5%

Updated Package Insert, December 2009.

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


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