News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Nov. 24, 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 Nov. 24, 2014. Times listed are local time.
 
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
 
Meetings, Workshops and Congressional Testimony:
 
Monday, 11/24 – Tuesday, 11/25 – The Anesthetic and Analgesic Drug Products Advisory Committee will meet to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling. The meeting will take place at 8 a.m. on both days on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov       
 
In Case You Missed It:
 
Friday, 11/21 – Federal Register Notice and New CDER Webpage: Drug Trials Snapshots. The FDA released a new webpage that will provide a clearinghouse for easy-to-understand and readily available information about the age, race, and sex of clinical trial participants in clinical studies of FDA-approved drugs and biologics. The information will be organized in a new document that FDA is calling Drug Trials Snapshots. Each Snapshot covers a single drug, providing a breakdown of the percentage of demographic subgroups participating in the drug’s pivotal clinical trials. Also included is information about how the trial was designed and whether there were any observed differences in side effects and efficacy by sex, age and race/ethnicity. Beginning next year, the FDA intends to post a Snapshot for every New Molecular Entity and original biologic we approve. But before we do that, we are seeking feedback from the public on the content, format and overall usability of the first six Snapshots. Comments can be submitted to the Federal Register Docket No. FDA-2014-N-1818.
Press Office Contact:  Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov          
 
Friday, 11/21 –FDA Voice Blog: China Journal: strengthening relationships to protect public health. FDA Commissioner, Margaret A. Hamburg traveled on a five-day trip to China. China is a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for the Commissioner’s trip is the important and growing collaboration between FDA and our counterpart agencies in China to ensure the safety of the large volume of foods and medical products exchanged between our two nations. Read the entire blog at FDA Voice.
Press Office Contact:  Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov           
 
Thursday, 11/20 – FDA Voice Blog: Additional progress on reducing the abuse of opioid pain relievers. The FDA’s approval of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate) marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. Hysingla ER’s approval provides prescribers with another option for managing pain severe enough to require daily, around-the-clock, long term opioid treatment in patients for whom alternative treatment options are inadequate, while potentially reducing hydrocodone abuse. Read the entire blog at FDA Voice.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov         
                                                      
Monday, 11/17 – Consumer Update: Have a Baby or Young Child With a Cold? Most Don't Need Medicines. Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold? FDA has some advice and tips.
Press Office Contact:  Sandy Walsh, 301-796-4669, sandy.walsh@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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Page Last Updated: 11/24/2014
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