News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of May 4, 2015  

 
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 May 4, 2015. 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:
 
Friday, 5/8 – FDA Acting Commissioner, Stephen Ostroff, M.D., will deliver remarks at the American Society of Microbiology Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens. The conference will take place beginning at 9 a.m. at the Omni Shoreham Hotel in Washington D.C.
Press Office Contact: Heidi Rebello, 301-796-4566, heidi.rebello@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Monday, 5/4 – The FDA will host a public workshop titled Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases. The purpose of the workshop is to engage in constructive dialogue among regulators, academicians, pharmaceutical industry, clinicians, other stakeholders and the general public on potential strategies to improve availability of information on important health factors in pharmacoepidemiology studies that rely on electronic healthcare databases to evaluate the safety of pharmaceutical products in the postapproval setting. The meeting will take place beginning at 8:30 a.m. on FDA’s White Oak campus, Silver Spring, Maryland. The meeting will also be available by webcast.
Press Office Contacts: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov and Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov   
 
Tuesday, 5/5 – Captain Valerie Jensen, Associate Director of the FDA’s Drug Shortages Program, will be a witness at the Senate Caucus on International Narcotics Control hearing titled Improving Management of the Controlled Substances Quota Process. The hearing will take place at 10 a.m. at the Dirksen Senate Office building, Washington, D.C.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
Tuesday, 5/5 – Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, will be a witness at the Senate Committee on Health, Education, Labor, and Pensions hearing titled Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients. The hearing will take place at 2:30 p.m. at the Dirksen Senate Office building, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov  
 
Wednesday, 5/6 – Steve Solomon, the FDA’s Deputy Associate Commissioner for Regulatory Affairs, will be a witness at the Senate Small Business Committee hearing titled Impact of Federal Labor and Safety Laws on the U.S. Seafood Industry. The hearing will take place at 2:30 p.m. at the Russell Senate Office building, Washington, D.C.
Press Office Contact: Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov  
 
In Case You Missed It:
 
Thursday, 4/30 – News Release: FDA approves Raplixa to help control bleeding during surgery. The FDA approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov  
 
Thursday, 4/30 – News Release: FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics. The FDA issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.com  
 
Wednesday, 4/29 – News Release: FDA approves treatment for fat below the chin. The FDA approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.com
 
Tuesday, 4/28 – News Release: FDA approves first generic Abilify to treat mental illnesses. The FDA approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov   
 
Monday, 4/27 – News Release: FDA enters consent decree with Medtronic, Inc. The FDA announced the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.
Press Office Contact: Christopher Kelly, 301-796-4676, christopher.kelly@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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