News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of May 23, 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 May 23, 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:
 
Wednesday, 5/25 – FDA Commissioner Robert Califf, M.D., will deliver a keynote address at the Big Data in Biomedicine: Enabling Precision Health conference at Stanford Medicine. The conference will take place beginning at 8 a.m. at the Li Ka Shing Center for Learning & Knowledge, Stanford, California.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Tuesday, 5/24 – The Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet to discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical’s AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The proposed use of the device is to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. The meeting will take place beginning 8 a.m. at the Hilton hotel, Gaithersburg, Maryland.
Press Office Contact: Deborah Kotz, 301-796-5249, deborah.kotz@fda.hhs.gov     
 
Tuesday, 5/24 – The Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss the safety and efficacy of new drug application 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed use: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov    
 
Wednesday, 5/25 – The Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss the safety and efficacy of new drug applications 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov    
 
On the Web:
 
Registration is now open – Public Meeting: Over-the-Counter Monograph User Fees. The FDA is announcing a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. The meeting will take place on June 10, 2016 at 9 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 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 FDA 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:
  
Friday, 5/20 – News Release: FDA modernizes Nutrition Facts label for packaged foods. The FDA took a major step in making sure consumers have updated nutritional information for most packaged foods sold in the United States, that will help people make informed decisions about the foods they eat and feed their families.
Press Office Contact: Lauren Kotwicki, 240-402-9549, lauren.kotwicki@fda.hhs.gov
 
Friday, 5/20 – FDA Voice Blog: Unveiling the New Nutrition Facts Label. The FDA has finalized the new Nutrition Facts label on packaged foods with changes that will make it easier for consumers to make informed choices about what they’re eating. Our goal is to help people make better informed food choices that support a healthy diet. The changes are based on updated science that reinforces the link between diet and chronic conditions such as obesity, heart disease and diabetes.
Press Office Contact: Lauren Kotwicki, 240-402-9549, lauren.kotwicki@fda.hhs.gov
 
Thursday, 5/19 – FDA Voice Blog: From Competition to Collaboration: precisionFDA Challenges. Next week, we will announce the winners of the first precisionFDA challenge. We set up precisionFDA as an online, cloud-based, virtual research space to allow scientists from academia, industry, health care organizations, and government to work together on creating tools to evaluate a method of “reading” DNA known as next generation sequencing (or NGS). The ultimate goal of precisionFDA is to foster innovation and develop regulatory science around NGS tests, which are essential to achieving the promise of President Obama’s Precision Medicine Initiative. So far, the response to precisionFDA has been gratifying, with participants calling precisionFDA “refreshing,” “innovative,” and “a new paradigm in regulatory science.” The community currently boasts more than 1,500 users from 600 organizations, with more than 10 terabytes of genetic data stored.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Wednesday, 5/18 – FDA News Release: FDA approves new, targeted treatment for bladder cancer. The FDA approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer.
Press Office Contact: Angela Stark, 301-796-0397, angela.stark@fda.hhs.gov  
 
Wednesday, 5/18 – Consumer Update: Lupus Therapies Continue to Evolve. May is National Lupus Awareness month, a time to think about lupus and the challenges it presents patients, researchers and health care professionals alike. Scientists today are working on many fronts to understand the genetic underpinnings of the disease and to develop new and more targeted therapies to treat it.
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
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