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Weekly Media Tip Sheet

 

FDA News & Notes – Week of Oct. 20, 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. 20, 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, 10/22 – FDA Commissioner Margaret A. Hamburg, M.D., and Janet Woodcock, M.D., director for FDA’s Center for Drug Evaluation and Research will deliver the keynote address at the National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit in Alexandria, Virginia.
Press Office Contact: Steven Immergut, 301-796-7507, steven.immergut@fda.hhs.gov
  
Friday, 10/24 – FDA Commissioner Margaret A. Hamburg, M.D., will deliver the keynote address at the 2nd Annual Pediatric Surgical Innovation Symposium, hosted by Children’s Hospital’s Sheikh Zayed Institute for Pediatric Surgical Innovation in Washington, DC.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Meetings, Workshops and Congressional Testimony:
 
Monday, 10/20 – The Dermatologic and Ophthalmic Drugs Advisory Committee will meet to discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The meeting will take place beginning at 8 a.m., on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov    
 
Tuesday, 10/21 – The FDA will hold a public workshop titled Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer. This workshop will provide a forum to explore means of accelerating the development of highly effective targeted agents for patients with metastatic breast cancer. The workshop will bring together an international group of breast cancer experts, FDA, industry representatives, and patient advocates to discuss the intricacies of developing an international genomically driven trial to test multiple agents in patients with metastatic breast cancer. Stakeholders will discuss potential biomarkers, testing platforms, study designs, statistical models, and implementation strategies to optimize the path to regulatory approval. The workshop will take place beginning at 8 a.m. at the Hyatt Regency Bethesda Hotel, Bethesda, Maryland.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov
 
Tuesday, 10/21 – The Pulmonary-Allergy Drugs Advisory Committee will meet to discuss the supplemental new drug application for ivacaftor oral tablets, submitted by Vertex Pharmaceuticals, for the treatment of cystic fibrosis in patients 6 years and older with a R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov           
 
Tuesday, 10/21 – Wednesday, 10/22 – The FDA will hold a two-day public workshop titled Collaborative Approaches for Medical Device and Healthcare Cybersecurity. This workshop will bring together all stakeholders in the healthcare and public health (HPH) Sector including but not limited to medical device manufacturers, healthcare facilities and personnel (e.g. healthcare providers, biomedical engineers, IT system administrators), professional and trade organizations (including medical device cybersecurity consortia), insurance providers, cybersecurity researchers, local, State and Federal Governments, and information security firms in order to identify HPH cybersecurity challenges and ways the Sector can work together to address these challenges. The workshop will take place beginning at 9 a.m. on both days at the National Intellectual Property Rights Coordination Center, Arlington, Virginia.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov  
 
On the Web:
 
Press Office Contact: Jennifer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov 
 
 
Tuesday, 10/14 Emergency Use Authorizations (2014 Ebola Virus Emergency Use Authorizations)
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov  
 
In Case You Missed It:
 
Friday, 10/17 – News Release: FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic. The FDA approved approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an 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. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov   
 
Friday, 10/17 – FDA Voice Blog: FDA Invites Students to Sharpen their Research Skills. Biology. Chemistry. Bioinformatics. Toxicology. Practical, hands-on laboratory work is important for all college students who want to become scientists—but, for many of them, such experiences are out of reach. Read the entire blog at FDA Voice.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
 
Thursday, 10/16 – Consumer Update: FDA Builds Closer Ties with Mexico. Many of the goods that we enjoy every day are imported from Mexico. These include foods such as tomatoes and avocados, lower-risk medical devices such as surgical drapes, and FDA-approved medications.
Press Office Contact: Gloria Sánchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov       
 
Wednesday, 10/15 – News Release: FDA approves Ofev to treat idiopathic pulmonary fibrosis. The FDA approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov      
 
Wednesday, 10/15 – News Release: FDA approves Esbriet to treat idiopathic pulmonary fibrosis. The FDA approved approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov      
 
Wednesday, 10/15 – FDA Voice Blog: Two FDA drug approvals for idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis is a disease in which tissue deep inside the lungs becomes thick, stiff, and scarred, decreasing the lungs’ ability to expand to take in air, and making it difficult to breathe. This is a progressive disease in which scarring and lack of elasticity in the lungs continues to increase until the patient can no longer breathe enough to sustain life. Read the entire blog at FDA Voice.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov      
 
Wednesday, 10/15 – FDA Voice Blog: FDA Working to Keep Patients Well Informed. The FDA’s Office of Health and Constituent Affairs (OHCA) is here to serve our nation’s patients in two ways: by listening to their concerns regarding FDA’s policy and decision-making and advocating for them in our agency; and by informing many patients and patient organizations about the FDA’s mission and its work to advance the development, evaluation and approval of new therapeutic products. Read the entire blog at FDA Voice.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov       
 
Wednesday, 10/15 – Consumer Update: Research Flash: FDA Scientists Study Pediatric Brain Function. Scientists at the FDA’s National Center for Toxicological Research are studying brain function. They’ve developed an innovative tool that lets children and animals play games that test memory, attention, motivation and time perception.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov       
 
Tuesday, 10/14 – News Release: Federal judge approves FDA consent decree with Ascend Laboratories. A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the FDA.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov           
 
Tuesday, 10/14 – News Release: FDA permits marketing of urinary prosthesis device for women. The FDA allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov                  
 
Tuesday, 10/14 – FDA Voice Blog: FDA’s giant NMR magnet puts more imaging power into our regulatory science. The word spin might make you think of someone trying to influence your opinion. But in physics, spin refers to an intrinsic property of certain subatomic particles that make some nuclei act like small magnets. That kind of spin is key to a powerful laboratory technique scientists use to study complex, carbon-based biological products at the atomic and molecular level. Read the entire blog at FDA Voice.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov                        
 
Tuesday, 10/14 – Consumer Update: FDA Helps Tackle Sickle Cell Disease. Sickle cell disease (SCD) is the most common inherited blood disorder in the United States. It affects about 100,000 children and adults in the United States—and millions of people worldwide. New treatments are needed to prevent and treat its serious complications. That’s why the FDA is working with patients and stakeholders, including those from academia and the pharmaceutical industry, to develop new products.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@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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