Latest FDA News and Information
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet... read more
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing... read more
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk... read more
Food and Drug Adminstration (FDA): CDRHNew
Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent
The FDA is announcing that a collection of information 'Medical Devices; Exception From General Requirements for Informed Consent' has been approved by OMB under the Paperwork Reduction Act... read more
Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
The FDA is announcing the issuance of an Emergency Use Authorization (EUA) for an in vitro diagnostic device for detection of the Ebola Zaire virus (detected in the West Africa... read more
Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis - Guideline for Industry and Food and Drug Administration Staff (PDF - 142KB)
A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis... read more
In the past year, FDA has given adults new options for treating migraines by allowing the marketing of two prescription devices for such headaches.