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Weekly Media Tip Sheet

 

FDA News & Notes – Week of July 28, 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 July 28, 2014. 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 7/30– FDA Commissioner Margaret Hamburg, M.D., will deliver opening remarks at “The Development of New Antibacterial Products: Chartering a Course for the Future,” an NIH-FDA sponsored workshop being held in Bethesda, Maryland.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Wednesday, 7/30 – Thursday 7/31 – NIH and FDA will host a two-day workshop, “The Development of New Antibacterial Products: Charting a Course for the Future,” to explore key issues and challenges related to antibacterial product development and discuss the development of streamlined regulatory pathways for bringing new antibacterial drugs to market. The workshop aims to identify strategies for promoting clinical trials for antibacterial drugs and encouraging partnerships to accelerate the development of new antibacterial drugs. The workshop will take place at the Bethesda Marriott Hotel, Bethesda, Maryland.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov              
 
Wednesday, 7/30 – Thursday 7/31 –  On July 30, The Gastroenterology and Urology Devices Panel will hold a meeting to discuss, make recommendations, and vote on information regarding the premarket approval application for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed use for the Ablatherm Integrated Imaging device is for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. The meeting will take place beginning at 8 a.m. on both days at the Gaithersburg Hilton, Gaithersburg, Maryland.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Thursday 7/31 – The Blood Products Advisory Committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results. The meeting will take place at 8 a.m. on the FDA’s White Oak campus, Silver Spring Maryland.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
 
Friday 7/31 – The General and Plastic Surgery Devices Panel will meet to discuss, make recommendations and vote on information regarding the premarket application for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed use for the TissuGlu Surgical Adhesive device is for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. The meeting will take place beginning at 8 a.m. at the Gaithersburg Hilton, Gaithersburg, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
In Case You Missed It:
 
Thursday, 7/24 – News Release: The United States and Mexico sign statement of intent to strengthen produce safety. The FDA and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the safety of fresh and minimally processed agricultural products.
Press Office Contacts: Gloria Sanchez-Contreras, 301-796- 7686, gloria.sanchez-contreras@fda.hhs.gov or Fallon Smith, 301-796-8632, fallon.smith@fda.hhs.gov       
 
Thursday, 7/24 – FDA Voice Blog: On the road from Mexico: a model for regulatory cooperation. This week Margaret A. Hamburg, M.D., made her first visit to Mexico as FDA Commissioner and, while she enjoyed the rich culture, warm people and delicious food, the trip provided her with a vital first-hand perspective of the long-standing, productive and collaborative working relationship the FDA maintains with our regulatory counterparts in this wonderful country. Read the entire blog at FDA Voice.
Press Office Contact: Gloria Sanchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov
 
Thursday, 7/24 – FDA Voice Blog: A Milestone in our Partnership with Mexico on Food Safety. The FDA knows that food safety is more a journey than a destination, but there are times when we can point to a major milestone along the road. Today, we reached such a milestone in our long-standing relationship with Mexico by signing a statement of intent to establish a new produce safety partnership. Read the entire blog at FDA Voice.
Press Office Contact: Gloria Sanchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov
 
Thursday, 7/24 – FDA Voice Blog: Dr. Frances Kelsey, Who Protected Americans from Thalidomide, Turns 100. Today marks the 100th birthday of one of America’s most celebrated public servants. Frances Oldham Kelsey, Ph.D., M.D., was born in Cobble Hill, Vancouver Island, British Columbia, and earned her Ph.D. in pharmacology and her M.D. at the University of Chicago. She was on the faculty of the University of South Dakota and practicing medicine when, in 1960, she accepted the offer to become a medical officer at the FDA. Read the entire blog at FDA Voice.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Thursday, 7/24 – FDA Voice Blog: A reminder of the promise and limitations of abuse-deterrent properties. The ongoing growing amount of drug abuse in our nation, particularly with prescription pain relievers known as opioids, has prompted a lot of talk about the potential of opioids with “abuse-deterrent” properties to help combat this public health problem. But care must be taken in putting too much promise into abuse-deterrent technology at this time because the science is still relatively new and evolving. Read the entire blog at FDA Voice.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Thursday, 7/24 – Consumer Update: Faster, Easier Cures for Hepatitis C. Transformative advances in drug treatments approved by the FDA are giving the 3.2 million Americans with chronic hepatitis C a chance for a longer, healthier life without the virus. That’s welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of whom don’t yet know they are infected and carriers.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Wednesday, 7/23 – News Release:  FDA approves Zydelig for three types of blood cancers. The FDA approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities).
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov  
 
Wednesday, 7/23 – News Release: FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals. The FDA is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.
Press Office Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov     
 
Wednesday, 7/23 – News Release:  FDA approves new extended-release oxycodone with abuse-deterrent properties. The FDA approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@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
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
 
 
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