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FDA approves new antibacterial drug Avycaz

The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated... read more

FDA approves Farydak for treatment of multiple myeloma

The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.

FDA approves closure system to permanently treat varicose veins

The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using... read more

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome

The U.S. Food and Drug Administration today authorized for marketing 23andMe?s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a... read more

Food and Drug Adminstration (FDA): CDRHNew

Class I Medical Device Recall: HeartWare Ventricular Assist System (VAS) ? Electrostatic Discharge May Cause Pump Failure

A buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pump?s operation... read more

Federal Register: Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments

The FDA is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and... read more

Consumer Information on: VenaSeal Closure System - P140018

The VenaSeal Closure System (VenaSeal System) is intended to permanently treat varicose veins of the legs that cause symptoms by sealing the affected veins that are closest to the skin (... read more

Federal Register: Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System

The FDA is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order,... read more

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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

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