News & Events

Weekly Media Tip Sheet

 

FDA News & Notes – Week of Feb. 23, 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 Feb. 23, 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:
 
Monday, 2/23 – Tuesday, 2/24 – The Pharmacy Compounding Advisory Committee will meet to discuss proposed revisions to the list of drug products that may not be compounded under the exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. They will also discuss proposed criteria for developing the list of bulk drug substances that may be used to compound drug products in accordance with section 503A of the FD&C Act and will discuss six substances nominated for inclusion on the list. The meeting will take place beginning at 8:30 a.m. on Monday and 8:15 a.m. on Tuesday on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov 
 
Tuesday, 2/24 – The FDA will hold a webinar titled Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories. The webinar is intended to give an overview of FDA’s approach to regulating MDDS and to help stakeholders understand the draft policies described in the general wellness and medical device accessories guidance documents and solicit comments.  Following a brief presentation, the FDA will respond to questions regarding all four guidance documents. The webinar will begin at 2 p.m. Registration is not necessary.
Press Office Contact: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
 
Tuesday, 2/24 – The Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee will hold a joint meeting to discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov 
 
Friday, 2/27 – The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet to discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands.
Press Office Contact: Eric Pahon, 240-402-4177, eric.pahon@fda.hhs.gov
 
In Case You Missed It:
 
Friday, 2/20 – News Release: FDA approves closure system to permanently treat varicose veins. The FDA approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
Press Office Contact: Leslie Wooldridge, 240-402-4504, leslie.wooldridge@fda.hhs.gov
 
Thursday, 2/19 – News Release: FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom Syndrome. The FDA authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.
Press Office Contacts: Eric Pahon, 240-402-4177, eric.pahon@fda.hhs.gov and Jennifer Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov      
 
Thursday, 2/19 – FDA Voice Blog: Recent Progress on Demographic Information and Clinical Trials. At the FDA, one of our foremost responsibilities is to evaluate and if medical products meets the appropriate standard, to approve or clear drugs, biological products and medical devices. We know that these products are safer and more effective for everyone when they are tested in clinical trials that include diverse populations. Read the entire blog at FDA Voice.
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
 
More Resources:
Read our Blog: FDA Voice
FDA Photos (Flickr)
 
 
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