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Weekly Media Tip Sheet


FDA News & Notes – Week of July 21, 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 21, 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, 7/21 – Friday 7/25 – FDA Commissioner Margaret Hamburg, M.D., will travel to Mexico City, Mexico to meet with regulatory counterparts in Mexico.
Press Office Contact: Steven Immergut, 301-796-7507, steven.immergut@fda.hhs.gov
In Case You Missed It:
Friday, 7/18 – FDA Voice Blog:  Achieving an AIDS Free Generation - Highlights from the PEPFAR Annual Meeting in Durban, South Africa. The U.S. Global AIDS Coordinator, Ambassador Deborah Birx, recently described the President’s Emergency Plan for AIDS Relief (PEPFAR) as “one of the greatest expressions of American compassion, ingenuity, and shared humanity in our nation’s rich history.” Read the entire blog at FDA Voice.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov              
Thursday, 7/17 – Statement: Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs. The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.
Press Office Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov     
Thursday, 7/17 – News Release: FDA approves new product to treat rare genetic disease. The FDA approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov           
Thursday, 7/17 – FDA Voice Blog:  A Curriculum for Medical Device Progress. Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” -- and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In scores of meetings and two large workshops, we consulted with hundreds of academics about a novel idea: a university-level program to address an important public health need by stimulating the development of new medical devices. Read the entire blog at FDA Voice.
Press Office Contact: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov            
Thursday, 7/17 – Consumer Update: Juvenile Arthritis: New Discoveries, New Treatments. Juvenile arthritis is one of the most common chronic illnesses affecting children. And July is Juvenile Arthritis Awareness Month, a fitting time to learn more about this disease.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov     
Wednesday, 7/16 – Statement: Update on findings in the FDA cold storage area on the NIH campus. As previously reported, on July 1, 2014, biological samples were found in the cold storage area of FDA laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov        
Wednesday, 7/16 – FDA Voice Blog: OpenFDA Provides Ready Access to Recall Data. Every year, hundreds of foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be ordered by the U.S. Food and Drug Administration. Recalls are reported to the FDA, and compiled into its Recall Enterprise System, or RES. Every week, the FDA releases an enforcement report that catalogues these recalls. And now, for the first time, there is an Application Programming Interface (API) that offers developers and researchers direct access to all of the drug, device, and food enforcement reports, dating back to 2004. Read the entire blog at FDA Voice
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov         
Tuesday, 7/15 – FDA Voice Blog: Developing new tools to support regulatory use of "Next Gen Sequencing" data. When you’re thirsty, you don’t want to take a drink from a fire hose. And when scientists are looking for data they don’t want to be knocked over with a flood of information that overwhelms their ability to analyze and make sense of it. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Rodriguez, 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
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
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