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Latest FDA News and Information

FDA approves Repatha to treat certain patients with high cholesterol

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment... read more

FDA takes action against three tobacco manufacturers for making ?additive-free? and/or ?natural? claims on cigarette labeling

Today the U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers ? ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman?s 1400 Broadway N.Y.... read more

FDA extends use of Promacta in young children with rare blood disorder

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients ? ages one year and older ? with a rare blood disorder... read more

FDA approves first treatment for sexual desire disorder

The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi?s approval, there were... read more

Food and Drug Adminstration (FDA): CDRHNew

Class I Medical Device Recall: CareFusion Alaris Syringe Pump Alarm Error May Cause Interruption of Therapy

An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the... read more

Class I Medical Device Recall: Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane, Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump

Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or... read more

Summary Information for: Innova Vascular Self-Expanding Stent System

Labeling, Approval Order, and Summary of Safety and Effectiveness for Innova Vascular Self-Expanding Stent System (P140028).

Summary Information for: Minerva Endometrial Ablation System

Labeling, Approval Order, and Summary of Safety and Effectiveness for Minerva Endometrial Ablation System (P140013).

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

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

CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents

This list includes only vaccines for which supporting documents were provided and is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new... read more

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