News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Jan. 20, 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 Jan. 20, 2015. 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:
 
Thursday 1/22 – The Anti-Infective Drugs Advisory Committee will meet to discuss Astellas Pharma’s isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, a new antifungal drug to treat invasive aspergillosis and mucormycosis infections. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland. The meeting will also be webcast.
Press Office Contacts: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov  and Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov
 
In Case You Missed It:
 
Friday, 1/16 – News Release: Federal judge approves consent decree with California dietary supplement maker. A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.
Press Office Contact: Jennifer Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov          
 
Friday, 1/16 – FDA Voice Blog: Australia, Brazil, Canada, Japan, and the US: Safeguarding Medical Devices. The FDA and its regulatory counterparts abroad have the weighty responsibility of ensuring the safety of the thousands of regulated medical devices imported in their countries each year. To make this task more manageable, the FDA and regulatory agencies in Australia, Brazil, Canada, and Japan embarked in 2014 on a pilot called the Medical Device Single Audit Program (MDSAP). Its goal is to develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied, in an efficient yet thorough manner. Read the entire blog at FDA Voice.  
Press Office Contact: Leslie Wooldridge, 240-402-4504, leslie.wooldridge@fda.hhs.gov                
 
Thursday, 1/15 – Consumer Update: Need Relief From Overactive Bladder Symptoms? Have an overactive bladder? More than 33 million Americans do. FDA-approved treatments can help adults of any age control their symptoms. They include oral medications, a patch or gel applied to the skin, the first over-the-counter (OTC) treatment for women with overactive bladder, and bladder injections for patients with more severe symptoms.
Press Office Contact: Andre Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
Wednesday, 1/14 – News Release: FDA approves first-of-kind device to treat obesity. The FDA approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. 
Press Office Contact: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov 
 
Wednesday, 1/14 – FDA Voice Blog: CDER Approved Many Innovative Drugs in 2014. Each year, the FDA’s Center for Drug Evaluation and Research (CDER) will typically approve more than 100 new medications. A portion of those are novel new drugs, medications that have not previously been approved by the FDA and are often among the most innovative products serving previously unmet medical needs or otherwise significantly helping to advance patient care and public health. Read the entire blog at FDA Voice.
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: 01/20/2015
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