News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of Sept. 26, 2016

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 Sept. 26, 2016. 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, 9/28 – FDA Commissioner Robert Califf, M.D., will deliver a keynote address at the 2016 Clinical Data Interchange Standards Consortium International Interchange. The event will take place at the Marriott Hotel and Conference Center, Bethesda, Md.
Press Office Contact: FDA Office of Media Affairs, 301-796-8632, fdaoma@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:

Monday, 9/26 –The European Medicines Agency and the FDA are hosting the EU-US collaboration to boost medicine development for rare diseases. The new cluster on rare diseases is to share experiences and best practices on each other’s regulatory approach to the development of medicines for these diseases. The cluster will provide a forum for confidential exchange of draft documents, policies under development, and more detailed information supporting the scientific basis for decision making on medicine development.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov.

Thursday, 9/29 – The FDA is hosting a public workshop on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices. The workshop is to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or Antimicrobial Susceptibility Tests and who wish to coordinate development of these products, such that the Antimicrobial Susceptibility Test device could be cleared either at the time of new drug approval or shortly thereafter. The workshop will take place beginning at 9 a.m. at the Sheraton Hotel, Silver Spring, Md. 
Press Office Contact: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov

In Case You Missed It:

Friday, 9/23 – News Release: FDA approves expanded indications for Ilaris for three rare diseases. The FDA approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients.
Press Office Contact: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov 

Friday, 9/23 – News Release: FDA approves Amjevita, a biosimilar to Humira. The FDA approved approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Press Office Contact: Theresa Eisenman, 301-796-2969, theresa.eisenman@fda.hhs.gov 

Wednesday, 9/21 – Consumer Health Information: What's in a Name? What Every Consumer Should Know About Foods and Flavors. Many foods or beverages are flavored—but how can you tell where those flavors come from? For example, if you’re digging into a bowl of cereal that has the word “maple” on the package, and even images of maple leaves, you may think you’re eating a product that contains maple syrup. But not so fast—the taste may come from added flavors.
Press Office Contact: FDA Office of Media Affairs, 301-796-8632, fdaoma@fda.hhs.gov 

Tuesday, 9/20 – Consumer Health Information: 4 Medication Safety Tips for Older Adults. Whether you’re settling into your sixties or heading into your ninth decade, be careful when taking prescription and over-the-counter medicines, herbal preparations, and supplements. And if you’re caring for older loved ones, help them stay safe, too.
Press Office Contact: FDA Office of Media Affairs, 301-796-8632, fdaoma@fda.hhs.gov 

Monday, 9/19 – News Release: FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.. The FDA
Press Office Contact: Michael Felberbaum, 240-402-9548, michael.felberbaum@fda.hhs.gov 

Monday, 9/19 – News Release: FDA grants accelerated approval to first drug for Duchenne muscular dystrophy. The FDA approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov  

Monday, 9/19 – FDA Voice Blog: First Major FSMA Compliance Dates: Landmarks and Learning Experiences. The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. That’s where we are today with the arrival of the first major compliance dates under the regulations developed by the FDA to implement the FDA Food Safety Modernization Act.
Press Office Contact: FDA Office of Media Affairs, 301-796-8632, fdaoma@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
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Consumer Health Information

Page Last Updated: 09/26/2016
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