News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Dec. 15, 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 Dec. 15, 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:
 
Thursday, 12/18 – FDA Commissioner Margaret A. Hamburg, M.D., will deliver the Keynote Address at “A One Health Colloquium – Science, Society and AMR and Global collaboration, trade and capacity building around AMR” in London, England.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov 
      
Meetings, Workshops and Congressional Testimony:
 
Tuesday 12/16 – Wednesday 12/17 – The Food Advisory Committee will meet to discuss science issues surrounding susceptible life stages or populations and the circumstances under which the FDA might decide to conduct a separate risk assessment for these populations. Also, the FDA is requesting advice from the Food Advisory Committee on how to integrate concern for susceptible populations into its risk assessment procedures and methodologies including under what conditions a separate risk assessment should be conducted. The meeting will take place beginning at 8:30 a.m. on both days on the FDA’s White Oak Campus, Silver Spring, Maryland.  
Press Office Contact: Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov
 
Thursday, 12/18 – The FDA is holding a closed session joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting will be closed to permit discussion of whether the FDA should permit further clinical development of an existing investigational drug product, which will include the review of trade secret and/or confidential information. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov        
 
In Case You Missed It:
 
Friday, 12/12 – News Release: FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer. The FDA expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov            
 
Wednesday, 11/26 – News Release: Reflecting on our steps to give Americans more informed food choices. In evaluating public health issues, FDA must often make difficult decisions and strike delicate balances. For an issue like menu labeling that touches so many people and must address the complexities of our modern food system, it is natural that there would be a wide range of views. So we appreciate the very positive reactions to our rules from the restaurant industry, the vending industry, consumer groups and public health experts. Read the entire blog at FDA Voice.
Press Office Contact: Jennifer Corbett Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov   
 
Friday, 12/12 – News Release: RZM Food Factory to cease operations for repeated food safety violations. William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements. The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the U.S. District Court of Hawaii on Dec. 11, 2014.
Press Office Contact: Lauren Sucher, 240-402-4793, lauren.sucher@fda.hhs.gov             
 
Thursday, 12/11 – News Release: FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies. The FDA approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov          
 
Thursday, 12/11 – FDA Voice Blog: 2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them. Preliminary data announced last week shows that 2014 is shaping up to be another strong year for novel drug approvals, which is certainly good news for many patients and their families. Read the entire blog at FDA Voice.
Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov           
 
Wednesday, 12/10 – News Release: FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV. The FDA approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov          
 
Monday, 12/8 – News Release: OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries. OtisMed Corporation (OtisMed) and its former chief executive officer, Charlie Chi, admitted today to intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the U.S. Food and Drug Administration. OtisMed also agreed to pay more than $80 million to resolve related criminal and civil liability.
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)
 
 
# # #

 

Page Last Updated: 12/17/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.