News & Events

Weekly Media Tip Sheet

FDA News & Notes – Week of Feb. 27, 2017

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. 27, 2017. 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:

Tuesday, 2/28 – Acting Commissioner of Food and Drugs Stephen Ostroff, M.D. will speak at the Global Food Safety Conference disclaimer icon. The event runs through March 2, 2017 in Houston, Texas.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov

Meetings, Workshops and Congressional Testimony:

Thursday, 3/2 – The FDA will testify before the House Committee on Energy and Commerce, Subcommittee on Health at a 10 a.m. hearing on Examining FDA’s Generic Drug and Biosimilar User Fee Programs
Press Office Contact: Jennifer Dooren, 301-796-2983, jennifer.dooren@fda.hhs.gov

In Case You Missed It:

Friday, 2/24 – FDA Voice Blog: 2016: A Record-setting Year for Generic Drugs and FDA Office of Generic Drugs Annual Report for 2016. Last year was a record-setting year for FDA’s generic drug program, a result that will help generate further cost savings for American consumers. FDA generated the highest number of approvals in the history of FDA’s generic drug program – more than 800 generic drug approvals, including both full approvals and tentative approvals. Last year’s performance surpassed 2015’s previous record of 726. Many of these approvals were for “first-time generic drugs,” meaning the introduction of a generic counterpart for a brand-name product for which there was previously no generic.
Press Office Contact: Sandy Walsh, 301-796-4540, sandy.walsh@fda.hhs.gov

Thursday, 2/23 – News Release: FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis. The FDA cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov

Thursday, 2/23 – News Release: FDA allows marketing of test to identify organisms that cause bloodstream infections and provide antibiotic sensitivity results. The FDA allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it takes to provide this important information, which can guide antibiotic treatment recommendations more quickly.
Press Office Contact: Tara Goodin, 240-402-3157, tara.goodin@fda.hhs.gov

Thursday, 2/23 – Consumer Health Information: Treating Migraines: More Ways to Fight the Pain. Thought there was no hope for treating your migraine headaches? Don’t give up.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov

Tuesday, 2/21 – News Release: Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations. U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana recently entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws.
Press Office Contact: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov

FDA Office of Media Affairs Contact Information:

Media Inquiries: FDA Office of Media Affairs, 301-796-4540, fdaoma@fda.hhs.gov
List of FDA Press Officers and beats

More Resources:

Read our Blog: FDA Voice
FDA Photos disclaimer icon (Flickr)
Consumer Health Information
Scientific Publications by FDA Staff

Page Last Updated: 02/27/2017
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