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Latest FDA News and Information

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

Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display

The FDA is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and... read more

Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use

The FDA is classifying the high throughput genomic sequence analyzer for clinical use into class II (special controls). The special controls that will apply to the device are identified in... read more

Federal Register: Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments

The FDA has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of... read more

Federal Register: Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device

The FDA is classifying the vibratory counter-stimulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be... read more

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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