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Weekly Media Tip Sheet


FDA News & Notes – Week of August 25, 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 August 25, 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:
Monday, 8/25 – Wednesday, 8/27 – FDA Commissioner Margaret A. Hamburg, M.D., will participate in The International Conference of Drug Regulatory Authorities (ICDRA) Meeting in Rio de Janeiro, Brazil. ICDRA is a strategic opportunity to drug regulatory authorities to become closer, discuss trends and challenges, but also to share solutions found at different parts of the globe.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
On the Web:
Friday, 8/22 – Fast Facts: 2014 Ebola Outbreak in West Africa
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs
In Case You Missed It:
Friday, 8/22 – FDA Voice Blog: FDA Works to Mitigate the West Africa Ebola Outbreak. The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. To date, more than two thousand people in Guinea, Liberia, Nigeria and Sierra Leone have become infected, and more than twelve hundred have died. The stories of so many lives lost, and those of so many others fighting for their lives, are heartbreaking and tragic. We at the FDA are dedicated to helping end this outbreak as quickly as possible. And we are working hard to accelerate the production and development of treatments and vaccines to help prevent future outbreaks like this. Read the entire blog at FDA Voice.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs    
Wednesday, 8/20 – FDA Voice Blog: Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency. The FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Read the entire blog at FDA Voice.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov  
Wednesday, 8/20 – News Release: FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes. The FDA allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov 
Tuesday, 8/19 – News Release: FDA approves new drug to treat a form of Gaucher disease. The FDA approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov                   
Monday, 8/18 – FDA Voice Blog: Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling. Every prescription drug (including biological drug products) approved by the FDA for human use comes with FDA-approved labeling. The labeling contains information necessary to inform healthcare providers about the safe and effective use of the drug for its approved use(s). Once a prescription drug is approved, the labeling may be updated as new information becomes available, including, for example, new approved uses, new dosing recommendations, and new safety information. Thus, the approved labeling is a “living document” that changes over time to reflect increased knowledge about the safety and effectiveness of the drug. Read the entire blog at FDA Voice.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@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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