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FDA approves Zinbryta to treat multiple sclerosis

The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is... read more

FDA approves new diagnostic imaging agent to detect recurrent prostate cancer

The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate... read more

FDA approves first buprenorphine implant for treatment of opioid dependence

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose... read more

FDA issues final food defense regulation

The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale... read more

Food and Drug Adminstration (FDA): CDRHNew

2014 Ebola Virus Emergency Use Authorizations: Idylla™ Ebola Virus Triage Test (Biocartis NV) - May 26, 2016

On May 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Idylla™ Ebola Virus Triage Test for the presumptive detection of Ebola Zaire virus (... read more

Mammography Facility Adverse Event and Action Report - May 27, 2016: Hawaii Radiologic Associates, Ltd.

On December 21, 2015, the American College of Radiology (ACR), on behalf of the Food and Drug Administration (FDA), initiated an Additional Mammography Review (AMR) of mammograms performed by this facility to... read more

Class I Medical Device Recall: Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk

Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the... read more

24 Hour Summary posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee

24 Hour Summary posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee

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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

Package Insert and Patient Information - Rotarix

Package Insert - TWINRIX

Complete List of Substantially Equivalent 510(k) Device Applications

Information updated through April 30, 2016

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