News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of June 20, 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 June 21, 2016. Times listed are local time.

FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Events and Speeches for the Commissioner and FDA Leadership:
 
Thursday, 6/23 – Friday, 6/24 – FDA Commissioner Robert Califf, M.D., will participate in a panel discussion on the Zika virus and deliver a speech on evidence generation at the 2016 Aspen Ideas Festival. This event will take place in Aspen, Colorado.
Press Office Contact: Katie Conover, 301-796-4540, priscilla.conover@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, “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 Sept. 8, 2016 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, “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The hearing will take place on Sept. 12-13, 2016 at 9 a.m. on the NIH Campus, Bethesda, Maryland.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
In Case You Missed It:
  
Wednesday, 6/15 – FDA Voice Blog: A Tale of 3 Countries: Applying FSMA Standards Globally. Over the past two months, FDA delegations has been visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States with the FDA Food Safety Modernization Act (FSMA), each country we visited is addressing their national food safety objectives in unique and creative ways. And each has committed to taking a strong role in supporting compliance with the new food safety regulations mandated by FSMA.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Tuesday, 6/14 – News Release: FDA approves AspireAssist obesity device. The FDA approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
Press Office Contact: Deborah Kotz, 301-796-5349, deborah.kotz@fda.hhs.gov       
 
Tuesday, 6/14 – FDA Voice Blog: Be A Champion for Clinical Trial Diversity. The FDA is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. The first part of the campaign was launched on June 19, 2016, World Sickle Cell Day, observed annually to help increase public knowledge and raise awareness of Sickle Cell Disease, which primarily affects people of African and Hispanic descent. We want to encourage diverse communities to learn more about how they can become a part of the research process to bring new therapies to the market.
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
List of FDA Press Officers and beats

More Resources:

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Page Last Updated: 06/21/2016
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