Latest FDA News and Information

FDA approves Movantik for opioid-induced constipation

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.

FDA approves weight-management drug Contrave

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

FDA allows marketing of the first test to assess risk of developing acute kidney injury

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

Treating Migraines: More Ways to Fight the Pain

In the past year, FDA has given adults new options for treating migraines by allowing the marketing of two prescription devices for such headaches.

What's New: Vaccines, Blood & Biologics RSS Feed

Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products

Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products


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