News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of April 26, 2016

 
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 April 26, 2016. Times listed are local time.
 
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.   
 
Meetings, Workshops and Congressional Testimony:
 
Tuesday, 4/26 – The FDA is co-sponsoring a workshop to discuss best practices for the use of patient-reported outcome (PRO) measures in oncology drug development. During this workshop, a broad array of international stakeholders involved in oncology drug development, utilization, and reimbursement will provide perspectives on the current approach to PRO assessment in oncology trials, explore the utility of information derived from existing PRO measures, and identify potential ways to improve alignment and strategic use of PRO measures to support drug development and better inform treatment decisions. The event is cosponsored by the Critical Path Institute’s (C-Path) Patient-Reported Outcome Consortium. The workshop is taking place beginning at 8 a.m. at the Sheraton Hotel, Silver Spring, Maryland.
Press Office Contacts:  Angela Stark, 301-796-0737, angela.stark@fda.hhs.gov and Sarah Peddicord, 301-796-2805, sarah.peddicord@fda.hhs.gov
 
Wednesday, 4/27 – Thursday, 4/28 – The FDA is holding a workshop on the evaluation of the safety of drugs and biological products used during lactation. The workshop is a forum to discuss the current state and future direction of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data to inform about potential risks of medication use during lactation and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation. The workshop will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.  
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
On the Web:
 
Registration is now open – Public Workshop; Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval: The FDA is announcing a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” The workshop will take place on September 8, 2016, beginning at 8:30 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
Registration is now open – Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products: The Food and Drug Administration is announcing a public hearing entitled, “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The two-day hearing will take place on September 12-13, 2016 beginning at 9 a.m. on both days on the NIH’s Campus, Rockville, Maryland.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
In Case You Missed It:
  
Friday, 4/22 – News Release: FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior. The FDA announced a proposal to ban electrical stimulation devices used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.
Press Office Contact: Deborah Kotz, 301-796-5349, deborah.kotz@fda.hhs.gov   
 
Wednesday, 4/20 – FDA Voice Blog: Strengthening Partnerships: FDA’s China Office Engages in Key Outreach with Chinese Provincial FDA, Academia, and Industry. ‘A single tree makes no forest, one string makes no music.’ This old Chinese proverb inspired the FDA’s China Office, as members of our staff embarked on a five-day trip to meet with provincial FDA regulators, industry, and academia in China’s Yangtze River Delta region.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Tuesday, 4/19 – News Release: FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens. The FDA announced that it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign’s target audience.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
 
Tuesday, 4/19 – FDA Voice Blog: What We Mean When We Talk About EvGen. Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the scientific evidence that supports medical product evaluation and clinical care decisions and the need to modernize methods and expectations surrounding this evidence base.  
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@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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