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Weekly Media Tip Sheet

 

FDA News & Notes – Week of Sept. 15, 2014  

 
Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of Sept. 15, 2014. Times listed are local time.
 
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
 
Events and Speeches for FDA Leadership:
  
Thursday, 9/18 – FDA Deputy Commissioner, Howard Sklamberg will participate in the 2014 Partnership for Safe Medicines Interchange conference. This conference will bring together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting. This conference will be held beginning at 8:30 a.m. at the Knight Conference Center at the Newseum, Washington, D.C.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Tuesday, 9/16 – Wednesday, 9/17 – The FDA will hold a conference entitled FDA and Product QRI Conference on Evolving Product Quality. This conference will serve as a forum for industry, academia, regulatory, and other pharmaceutical professionals to discuss cutting-edge ideas and exchange resources related to pharmaceutical quality. The conference will take place beginning at 8:30 a.m. at the Bethesda North Marriott Hotel and Conference Center, North Bethesda, Maryland.
Press Office Contact: Christopher Kelly, 301-796-4647, christopher.kelly@fda.hhs.gov or Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
 
Wednesday, 9/17 – The FDA will host the Generic Drug User Fee Amendments of 2012 Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. The hearing will take place beginning at 9 a.m. at the College Park Marriott Hotel and Conference Center, Hyattsville, Maryland.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Wednesday, 9/17 – Thursday 9/18 – The Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a two-day joint meeting to discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. The two-day meeting will take place beginning at 8 a.m. on both days at the College Park Marriott Hotel and Conference Center, Hyattsville, Maryland.
Press Office Contact: Morgan Liscinsky, 301-795-0397, morgan.liscinsky@fda.hhs.gov
 
Thursday, 9/18 – The Cellular, Tissue and Gene Therapies Advisory Committee will hold a public meeting to hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, FDA. This meeting will take place beginning at 1 p.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
 
In Case You Missed It:
 
Thursday, 9/11 – FDA Voice Blog: Teachers Learn About the Science Behind Food Safety and Nutrition. This past July, middle and high school teachers got a taste of the latest food safety and nutrition information at the FDA’s 15th annual summer training program for school teachers. The week-long program aims to improve food safety and nutrition education in U.S. schools so students are better armed to make nutritious food choices and understand the proper handling of food. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov 
 
Wednesday, 9/10 – News Release: FDA approves weight-management drug Contrave. The FDA approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
Press Office Contact: Morgan Liscinsky, 301-795-0397, morgan.liscinsky@fda.hhs.gov
 
Wednesday, 9/10 – Consumer Update: FDA: Don’t Leave Childhood Depression Untreated. Every psychological disorder, including depression, has some behavioral components. Depressed children often lack energy and enthusiasm. They become withdrawn, irritable and sulky. They may feel sad, anxious and restless. They may have problems in school, and frequently lose interest in activities they once enjoyed.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Tuesday, 9/9 – News Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas. The FDA is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
Press Office Contact: Christopher Kelly, 301-796-4647, christopher.kelly@fda.hhs.gov
 
FDA Office of Media Affairs Contact Information:
 
FDA News & Notes Inquiries: Fallon Smith, 301-796-8632, fallon.smith@fda.hhs.gov
General Inquiries: Call or e-mail FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
 
 
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