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Weekly Media Tip Sheet

FDA News & Notes – Week of April 14, 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 April 14, 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, 4/16 – 4/18 – TheTobacco Products Scientific Advisory Committee will meet to discuss scientific issues pertaining modified risk tobacco products (MRTP). The Committee will consider scientific issues pertaining to dependence and addiction, receive information on population modeling in the assessment of tobacco product applications and will discuss possible approaches for evaluating information on the potential risks and benefits of a MRTP to the health of individual tobacco users and the population as a whole. The meeting will take place beginning at 8:30 a.m. each day at the FDA’s Center for Tobacco Products Rockville Campus, Rockville, Md.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
On the Web:
Tuesday, 4/8 – Web page update: More About National Health Related Items Code (NHRIC and NDC labeler codes for medical devices to be phased out under the UDI rule)
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov 
Wednesday, 4/9 – Extension of comment period for draft guidances on prescription point-of-care and over-the-counter blood glucose monitoring systems
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
In Case You Missed It:
Thursday, 4/11 – Consumer Update: FDA's MedWatch Safety Alerts: March 2014. After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems. FDA encourages health care professionals and consumers to report problems with regulated products. MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Press Office Contact: The Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
Thursday, 4/10 – News Release: FDA approves expanded indication for certain pacemakers and defibrillators used to treat heart failure. The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.
Press Office Contact: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Thursday, 4/10 – Consumer Update: Irritable Bowel Syndrome Treatments Aren't One-Size-Fits-All. Irritable bowel syndrome (IBS) is an often misunderstood and underdiagnosed condition that affects about 15.3 million people in the United States. No one remedy works for all patients, so there’s a great medical need to develop new therapies for IBS, says Andrew Mulberg, M.D., a gastroenterologist with the FDA. That’s why the FDA is working to bring more treatments to the market.
Press Office Contact: The Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
Wednesday, 4/9 – FDA Voice Blog: Crossing the Country to Connect with the Cancer Research Community. One of the goals of Mitchell Zeller, J.D., Director of FDA’s Center for Tobacco Products (CTP), is to get feedback from everyone interested in their groundbreaking work of regulating tobacco products. They’ve heard that some people outside the Beltway—meaning those beyond the nation’s capital—would appreciate the chance to interact with them. When they can, they make those opportunities happen. They especially want to hear more comments from the public on the scientific issues associated with their regulatory process. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
Wednesday, 4/9 – FDA Voice Blog: Recognizing Those Who Strive to Vanquish Alzheimer’s Disease. FDA Commissioner Margaret A. Hamburg, M.D. had the opportunity to take part in the Alzheimer’s Association’s (AA) Advocacy Forum and engage in a public discussion with the organization’s President and CEO Harry Johns about the FDA’s role in helping advance Alzheimer's disease research and the development of new treatment options and approaches. Read the entire blog at FDA Voice.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Monday, 4/7 – News Release: FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules. The FDA is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
Monday, 4/7 – FDA Voice Blog: FDA is Working Closely with Manufacturers of Meningitis B Vaccines. Meningitis has been in the news recently because of outbreaks of a specific strain (called “serogroup B” or “MenB”) on college campuses. Infections caused by MenB are uncommon in the U.S, but can be very serious. According to the Centers for Disease Control and Prevention (CDC), 160 of the 500 cases of meningococcal disease in the U.S. in 2012 were caused by MenB. There are vaccines licensed (approved) in the U.S. to prevent meningitis, but none include this strain. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Rodriquez, 301-796-8232, jennifer.rodriguez@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 email FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
List of FDA Press Officers and beats

More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
Consumer Health Information
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