News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Dec. 22, 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 Dec. 22, 2014. Times listed are local time.
 
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
  
On the Web:
 
Friday, 12/19 – FDA Investigates Listeria monocytogenes Illnesses Potentially Linked to Caramel Apples. The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local authorities are investigating a listeriosis outbreak potentially linked to commercially-produced, prepackaged caramel apples. Listeriosis is caused by the bacterium Listeria monocytogenes.
Press Office Contact: Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov
 
In Case You Missed It:
 
Friday, 12/19 – News Release: FDA approves new antibacterial drug Zerbaxa. The FDA approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov            
 
Friday, 12/19 – News Release: FDA approves Viekira Pak to treat hepatitis C. The FDA approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov            
 
Friday, 12/19 – News Release: FDA approves Lynparza to treat advanced ovarian cancer. The FDA granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov            
 
Friday, 12/19 – News Release: FDA approves pathogen reduction system to treat platelets. The FDA approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov             
 
Friday, 12/19 – FDA Voice Blog: Food Safety Together. Last week, Mary Lou Valdez and Julie Moss represented the FDA in Cape Town, South Africa, at the third annual conference of the Global Food Safety Partnership (GFSP). The FDA has been a strong supporter of the GFSP since 2012, when it was launched by the World Bank and Commissioner Margaret A. Hamburg, M.D., gave the keynote address at the first conference. The FDA provides the Partnership with financial support and technical expertise. Read the entire blog at FDA Voice.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov             
 
Thursday, 12/18 – FDA Voice Blog: Protecting the Public from Unsafe Compounded Drug Products. In 2012, a devastating outbreak of fungal meningitis linked to a contaminated compounded drug product tragically resulted in the loss of 64 lives and caused more than 751 illnesses, many of which were very serious. These events were a powerful reminder of the potential harm that could be caused by unsafe compounding products. Read the entire blog at FDA Voice.
Press Officer Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
 
Thursday, 12/18 – FDA Voice Blog: FDA’s Janet Woodcock, M.D., recognized by the Institute for Safe Medication Practices: Receives Lifetime Achievement Award for her career in public service. FDA’s mission is to protect and promote the health of the American public. The FDA employees who dedicate their careers to this worthy goal do so not for personal reward or public recognition but because of an extraordinary commitment to improving public healthcare. Which is why it is even more special when these employees receive public acclaim. Read the entire blog at FDA Voice.
Press Officer Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Thursday, 12/18 – FDA Voice Blog: Together: A Food Safe America. Michael R. Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine,  recently had the pleasure of speaking at the Consumer Food Safety Education Conference convened by the Partnership for Food Safety Education (PFSE). The conference brought together food safety educators from across the country – people in state and local health departments, universities, extension services, and food businesses who are working every day on the front line, with consumers, to reduce food safety risks by improving consumer food handling practices. Read the entire blog at FDA Voice.
Press Officer Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Wednesday, 12/17 – News Release: FDA approves Xtoro to treat swimmer’s ear. The FDA approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov          
 
Wednesday, 12/17 – Consumer Update: Got a Question About Your Pet's Health? Do you have questions about the foods, drugs, and other issues involving your pet? The FDA’s Center for Veterinary Medicine (CVM) may be able to answer them. The FDA regulates animal drugs, animal food (including pet food), and medical devices for animals, and conducts research that helps shape regulatory decisions, among other activities.
Press Office Contact: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov           
 
Tuesday, 12/16 – News Release: FDA approves first pathogen reduction system to treat plasma. The FDA approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov             
 
Tuesday, 12/16 – News Release: FDA announces Pharmacy Compounding Advisory Committee members. The FDA announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
Press Office Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov                        
 
Tuesday, 12/16 – FDA Voice Blog: Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine. On Tuesday, Dec. 9, Michael M. Landa met with the parents of two young men who died after using powdered pure caffeine. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov              
 
Tuesday, 12/16 – Consumer Update: Avoid Fetal "Keepsake" Images, Heartbeat Monitors. Fetal ultrasound imaging provides real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices designed to be used by trained health care professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov            
 
Monday, 12/15 – News Release: FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency. The FDA allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by the FDA for Severe Combined Immunodeficiency (SCID) in newborns.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov          
 
Monday, 12/15 – News Release: FDA clears test that helps predict the risk of coronary heart disease. The FDA cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
 
Monday, 12/15 – News Release: FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis. The FDA announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings.
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@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:
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