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FDA approves new psoriasis drug

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.

FDA approves drug to treat Duchenne muscular dystrophy

The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic... read more

Federal judge approves consent decree with California dietary supplement distributor, Regeneca Worldwide

A California dietary supplement distributor has been ordered by a federal court to stop selling its products, which were found to contain unsafe ingredients including 1, 3-dimethylamylamine (DMAA).

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

FDA Center for Drug Evaluation and Research - What's New

Important Information about this RSS Feed

This RSS news feed will end May 29 (Friday) due to changes in the FDA web site. You will need to re-subscribe to the What's New: Center for Drug Evaluation and... read more

Guidance for Industry

Bioequivalence Recommendations

Guidance for Industry

Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing

Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)

Current Drug Shortages: Technetium Tc99m Generators, See letter in Related Information Section

Food and Drug Adminstration (FDA): CDRHNew

Meeting materials posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Meeting materials posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Class I Medical Device Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate

Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which... read more

Check the CDRH Customer Satisfaction Results

This page provides real time results for CDRH's customer satisfaction survey.

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150038 and DEN150057 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150038 and DEN150057 added)

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

Gammaplex 5% & 10%

October 7, 2009 letter corrects the storage temperature stated on page 1, paragraph 5. Posted: 12/11/2009

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