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Weekly Media Tip Sheet

 

FDA News & Notes – Week of Oct. 27, 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 Oct. 27, 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:
 
Tuesday, 10/28 – FDA Commissioner Margaret A. Hamburg, M.D., will deliver a Grand Rounds Lecture at the Yale Cancer Center in New Haven, Connecticut.  
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Monday, 10/27 – The FDA will hold an industry meeting entitled Electronic Postmarket Safety Reporting Updates. The purpose of the meeting is to review changes in FDA postmarket safety reporting regulations, electronic submission processes and formats for Individual Case Safety Reports (ICSR) and ICSR attachments for drugs and biologics, including vaccines. The meeting will take place beginning at 9 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     
 
Monday, 10/27 – Tuesday, 10/28 – The FDA is conducting a Patient-Focused Drug Development public meeting and scientific workshop on Female Sexual Dysfunction (FSD). The FDA is interested in obtaining patient input on the impact of the most common form of FSD, female sexual interest/arousal disorder (FSIAD) on daily life and patients’ views on currently available therapies to treat the condition. The scientific workshop will include discussion on scientific challenges related to diagnosis of the condition for clinical trials and in clinical practice and ensuring valid patient-reported outcome measures for the key efficacy endpoints used in clinical trials. The workshop will take place beginning at noon on Monday and at 8 a.m. on Tuesday on the FDA’s White Oak Campus, Silver Spring, Maryland.    
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
 
Tuesday, 10/28 – Wednesday, 10/29 – The FDA, the Critical Path Institute and the Burroughs Wellcome Fund are co-sponsoring the First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates. This workshop will serve to map out the priorities of a new consortium devoted to applying regulatory science to the neonatal population. Academic experts, pharmaceutical companies, regulatory agencies in the US, Canada and Europe, patient foundations, NIH institutes, professional and other non-profit organizations will all have an opportunity to shape priorities and eventually join the new neonatal consortium. The Neonatal Roadmap Workshop will also address consortium governance and operations. The meeting will take place beginning at 8:30 a.m. on both days on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov    
 
Thursday, 10/30 – The Cardiovascular and Renal Drugs Advisory Committee will meet to discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart). The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
 
Thursday, 10/30 – Friday, 10/31 – The FDA will hold a public meeting entitled Development and Regulation of Abuse-Deterrent Opioid Medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties. The meeting will take place beginning at 8:30 a.m. on Thursday and at 3 p.m. on Friday at the Sheraton Hotel, Silver Spring, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
In Case You Missed It:
 
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
 
Friday, 10/24 – News Release: FDA approves new treatment for rare form of hemophilia. The FDA approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov    
 
Thursday, 10/23 – FDA Voice Blog: The more we know about rare diseases, the more likely we are to find safe and effective treatments. You may be inclined to think that rare diseases affect only a tiny fraction of the more than 320 million people in our country. That’s true about a single rare disease. But there are about 7,000 rare diseases. If you add them all together, there are about 30 million – or almost one in ten -- people in the U.S. with some form of rare disease. Sadly, although great progress has been made in some areas, many of these people have no FDA approved drug to cure their condition, help them feel better, or even slow the disease’s progress. Read the entire blog at FDA Voice.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov  
 
Thursday, 10/23 – Consumer Update: Finding Food Allergens Where They Shouldn't Be. If you’re allergic to a food ingredient, you probably look for it on the food product’s label. But some labels may not be as reliable as they should be. In fact, allergens not listed on the label, referred to as “undeclared allergens,” are the leading cause of food recalls requested by the FDA.
Press Office Contact: Theresa Eisenman, 301-796-2805, theresa.eisenman@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
List of FDA Press Officers and beats 
 
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
 
 
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