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Weekly Media Tip Sheet

 

FDA News & Notes – Week of Sept. 2, 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. 2, 2014. 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:
 
Wednesday, 9/3 – The Nonprescription Drugs Advisory Committee will hold a meeting to discuss the standards used to demonstrate that OTC topical antiseptics used in healthcare settings are generally recognized as safe and effective. The meeting will take place beginning at 8 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
 
Wednesday, 9/3 – Thursday 9/4 – The FDA will hold a public workshop entitled Hemostatic Medical Devices for Trauma Use. The purpose of this workshop is to obtain information on the current challenges and opportunities related to Hemostatic Medical Devices for use in emergency situations. Workshop participants will discuss factors that contribute to hemostatic medical device performance, reliability, and the types of studies that could potentially be used to evaluate appropriate bench testing, animal testing, bleeding severity, human factors, and clinical data collection for these products. The meeting will take place beginning at 8 a.m. on both days at the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Morgan Liscinsky, 301-795-0397, morgan.liscinsky@fda.hhs.gov
 
Thursday 9/4 – Friday 9/5 – The Sunscreen Advisory Committee will hold a meeting to discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in the U.S. OTC sunscreen products. The meeting will take place beginning at 8 a.m. on both days at the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
Friday 9/5 – The FDA will hold a public meeting entitled Advancing the Use of Biomarkers and Pharmacogenomics. The purpose of the public meeting is to initiate constructive discussion and information sharing on the advancement of biomarker science in the context of therapeutic product development among relevant stakeholders. The evolution of personalized medicine is dependent upon the development and application of clinically valid biomarkers, as well as companion diagnostics capable of accurately identifying and measuring a particular biomarker of interest. The meeting will take place beginning at 9 a.m. at the Washington Plaza Hotel, Washington, DC.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Friday 9/5 – The FDA will hold a public workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting. The workshop will focus on the clinical development of drugs for the prevention of serious infections caused by Staphylococcus aureus in the health care setting. The work shop will take place beginning at 8:30 a.m. at the DoubleTree by Hilton Hotel, Silver Spring, Maryland.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
On the Web
 
Wednesday, 8/27 – FDA has published a notice in the Federal Register announcing the availability of ten filed modified risk tobacco product (MRTP) applications for public comment. Click here for more information about MRTP applications and read the application files in full on the CTP website. Comments can be submitted at regulations.gov.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
 
In Case You Missed It:
 
Thursday, 8/28 – FDA Voice Blog: 50 States, One Goal: Working Together to Keep Our Food Safe. The August 12 conference in St. Louis of the Partnership for Food Protection (PFP) was truly a meeting of the minds. This 50-state workshop drew food and feed safety experts from federal, state, local, tribal and territorial government agencies. These organizations make up the PFP. Our shared goal? To continue working towards a food safety system in our country that makes our food as safe as possible. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Thursday, 8/28 – Consumer Update: Psoriasis Treatments Are Getting More Personalized. As scientists learn more about psoriasis, more therapeutic options are becoming available for patients with this skin disease. Understanding how psoriasis develops enables them to target different steps in the disease pathway to broaden the types of treatments available.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
Wednesday, 8/27 – Consumer Update: 4 Tips for a Healthy and Stress-Free Lunchbox. Stumped by what to pack in your child’s lunchbox? Whether your child is an athlete who needs extra calories for that after-school game or a teenager trying to maintain a healthy weight, here are four tips from the  FDA for making a nutritious lunch.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Monday, 8/25 – News Release: FDA takes action against Georgia dietary supplement manufacturer. A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the FDA’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov 
 
Monday, 8/25 – Consumer Update: WANTED: Consumers to Report Problems. Have you had an issue with a medicine, medical device, or food product and did not know who to notify? The FDA has a consumer-friendly form for reporting adverse events and other serious safety problems with FDA regulated products. The program that processes this information, and uses it to protect your health, is called MedWatch. And it needs your help.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@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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