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FDA Info

 



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

 

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

 

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

 

Federal Register: Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
The FDA is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls

 

Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System
The FDA is classifying tryptase test system devices into class II (special controls).

 

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

 

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

 

Draft Guidance for Industry: Design and Analysis of Shedding Studies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