News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of April 27, 2015  

 
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 27, 2015. 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:
 
Monday, 4/27 – The FDA’s Office of Regulatory Science and Innovation (ORSI) will host a one-day symposium titled 2015 ORSI Science Symposium. The purpose of this symposium is to showcase research underway in its programs to advance FDA's Regulatory Science Initiative. In addition to highlighting progress in ORSI-supported research projects, the 2015 ORSI Science Symposium will provide opportunities for stakeholders to further scientific collaboration within FDA’s scientific priority areas. The symposium will take place beginning at 7:30 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
Tuesday, 4/28 – The FDA will host a public meeting titled Chagas Disease Patient-Focused Drug Development. The purpose of this meeting is to obtain patient input on the impact of chagas disease on daily life and patients’ views on currently available therapies to treat the condition. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat Chagas disease. In the afternoon, FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease. The meeting will take place beginning at 9 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov    
 
Wednesday, 4/29 – The Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee will hold a joint meeting. The committees will discuss talimogene laherparepvec, Amgen, Inc., BLA 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
 
Thursday, 4/30 – Friday, May 1 – The Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee will meet to discuss and make recommendations regarding the classification of: Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, Vestibular Analysis Apparatuses. On May 1, the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. The meeting will take place beginning at 8 a.m. at the Hilton Washington Hotel, Gaithersburg, Maryland.
Press Office Contacts: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov, Deborah Kotz, 301-796-6549, deborah.kotz@fda.hhs.gov  
 
In Case You Missed It:
 
On April 23-24, 2015, the FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began on Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants include deputy FDA commissioners Michael Taylor and Howard Sklamberg, as well as leaders in the agency’s Office of Regulatory Affairs, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Thursday, 4/23 – News Release: Illinois food company agrees to stop production of contaminated sprouts. On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the FDA.
Press Office Contact: Fallon Smith, 301-796-8632, fallon.smith@fda.hhs.gov   
 
Tuesday, 4/21 – FDA Voice Blog: Congratulations to FDA’s Dr. Richard Pazdur, recipient of the American Association for Cancer Research's (AACR) prestigious Distinguished Public Service Award. In the past five years, the FDA’s Center for Drug Evaluation and Research (CDER) has approved more than 40 novel cancer treatments, offering hope to many patients who previously had few or no treatment options. Among these products are new and cutting-edge targeted therapies—sometimes called “precision medicines”—tailored to treat patients based on their individual characteristics. Read the entire blog at FDA Voice.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Tuesday, 4/21 – Consumer Update: Colorectal Cancer: What You Should Know. Last year in the United States, more than 136,000 people were diagnosed with—and more than 50,000 died from--colorectal cancer, according to the National Cancer Institute. It is the second leading cause of cancer-related deaths in the United States, striking some groups more often than others. The toll this disease takes on minorities is especially high, said Jonca Bull, M.D., director of FDA’s Office of Minority Health. Populations with limited access to screening and early treatment die much more often from the disease—African Americans, Hispanics, and American Indians and Alaska Natives. But there is a way of confronting this hazard, she added: “Early detection, referral, and treatment can significantly reduce disparities in deaths from colorectal cancer.”
Press Office Contact: Gloria Sanchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov  
 
Monday, 4/20 – FDA Voice Blog: FDA’s Keynote Address to the Annual Conference of the Food and Drug Law Institute. Today marks the start of my third week as Acting Commissioner of FDA for Dr. Stephen Ostroff. He “celebrated” by giving a keynote address to attendees at the annual conference of the Food and Drug Law Institute (FDLI). Few places offer a more appropriate stage for a newly designated leader of FDA. As our names suggest, our organizations have a lot in common. Read the entire blog at FDA Voice.
Press Office Contact: Heidi Rebello, 301-796-4566, heidi.rebello@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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