Latest FDA News and Information
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
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
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
Labeling, Approval Order, and Summary of Safety and Effectiveness for Innova Vascular Self-Expanding Stent System (P140028).
Labeling, Approval Order, and Summary of Safety and Effectiveness for Minerva Endometrial Ablation System (P140013).
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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
A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.
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