News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of July 27, 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 July 27, 2015. 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, 7/29 - FDA Acting Commissioner, Stephen Ostroff, M.D., will present at the FDA Science Board meeting. The Science Board will be provided with a report from the Commissioner’s Fellowship Program Evaluation subcommittee and will be provided with a progress report from the Science Looking Forward subcommittee. The meeting will take place beginning at 8:30 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland. For those unable to attend in person, the meeting will also be webcast.
Press Office Contact: Jeff Ventura, 301-796-7567, jeff.ventura@fda.hhs.gov
 
Meetings, Workshops and Congressional Testimony:
 
Monday, 7/27 and Tuesday, 7/28 – The FDA is holding a public workshop titled Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities. The purpose of this workshop is to obtain information on the current challenges and      opportunities related to robotically-assisted surgical medical devices, which are classified as Class II medical devices. The workshop will take place beginning at 8 a.m. on both days on the FDA’s White Oak Campus, Silver Spring, Maryland.
Press Office Contact: Eric Pahon, 240-402-4177, eric.pahon@fda.hhs.gov  
 
On the Web:
 
MCMi News and Events – The FDA is announcing the availability of a guidance for industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics.” This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. (Federal Register Notice)
Press Office Contact: Sarah Peddicord, 301-796-2805, sarah.peddicord@fda.hhs.gov
 
In Case You Missed It:
 
Friday, 7/24 – News Release: FDA approves new treatment for chronic hepatitis C genotype 3 infections. The FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov    
 
Friday, 7/24 – News Release: FDA approves Technivie for treatment of chronic hepatitis C genotype 4. The FDA approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov     
 
Friday, 7/24 – News Release: FDA approves new treatment for most common form of advanced skin cancer. The FDA approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
Press Office Contact: Sarah Peddicord, 301-796-2805, sarah.peddicord@fda.hhs.gov
 
Friday, 7/24 – News Release: FDA approves Praluent to treat certain patients with high cholesterol. The FDA approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
Press Office Contact: Eric Pahon, 240-402-4177, eric.pahon@fda.hhs.gov
 
Friday, 7/24 – News Release: FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars. The FDA proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families. The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.
Press Office Contacts: Lauren Kotwicki, 240-402-9549, lauren.kotwicki@fda.hhs.gov and Jennifer Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Friday, 7/24 – FDA Voice Blog: Putting Added Sugars Into Context for Consumers. For two decades, consumers have been able to check the Nutrition Facts label to understand not only how much saturated fat, dietary fiber and sodium is in any given food, but how that amount fits in the context of their daily diet. Today, FDA proposes a supplemental rule that would provide consumers with access to that same information for added sugars. This would fill a gap by providing the same valuable content already available to consumers for other nutrients.
Press Office Contacts: Lauren Kotwicki, 240-402-9549, lauren.kotwicki@fda.hhs.gov and Jennifer Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov
 
Friday, 7/24 – FDA Voice Blog: Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs. At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, the FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., and patients in this country will have earlier access to innovation.
Press Office Contact: Deborah Kotz, 301-796-5349, deborah.kotz@fda.hhs.gov
 
Thursday, 7/23 – News Release: FDA approves diagnostic test to differentiate between types of HIV infection. The FDA approved approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov    
 
Wednesday, 7/22 – News Release:  FDA Food Safety Challenge winners develop innovative technologies to detect Salmonellar. The FDA announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively.
Press Office Contact: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov  
 
Wednesday, 7/22 – FDA Voice Blog:  FDA Science Forum 2015: Views of FDA. The FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. See what some attendees said about the innovative research going on at the agency and why the FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development.
Press Office Contact: Leslie Wooldridge, 240-402-4504, leslie.wooldridge@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:
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