News & Events

Weekly Media Tip Sheet


FDA News & Notes – Week of Dec. 5, 2016

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 Dec. 5, 2016. 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, 12/5 – The FDA is hosting a public workshop on The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance. Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related adverse events in device surveillance and, more generally, device evaluation, has garnered increased scrutiny. This public workshop will further explore the critical role of hospitals in the evolution of device surveillance and in creating more robust surveillance capabilities. The meeting will be held at from 8:30 a.m. to 5 p.m. at the Fishers Lane Conference Center in Rockville, Maryland, and will be webcast.
Press Office Contact: Deborah Kotz, 301-796-5349,
Tuesday, 12/6 – The Bone, Reproductive and Urologic Drugs Advisory Committee will meet to discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis. The meeting will be held at from 8 a.m. to 5 p.m. at the Tommy Douglas Conference Center (10000 New Hampshire Ave., Silver Spring, Maryland). There will not be a free webcast.
Press Office Contact: Andrea Fischer, 301-796-0393,
In Case You Missed It:
Thursday, 12/1 – Consumer Health Information: The Facts on Bipolar Disorder and FDA-Approved Treatments. You or a loved one feel depressed. Then very excited, or even “hyper.” Then depressed again. These ups and downs can be a sign of bipolar disorder, a brain disorder. Though there is no cure for this disorder, medications approved by the U.S. Food and Drug Administration can treat symptoms and help you feel better.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540,
Wednesday, 11/30 – Consumer Health Information: Secondhand (and Third-Hand) Smoke May Be Making Your Pet Sick. If you’re a smoker, you probably realize the dangers smoking may pose to your health. But have you ever thought about how the habit affects your pet? According to Food and Drug Administration (FDA) veterinarian Carmela Stamper, D.V. M., the news is not good.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540,
Wednesday, 11/30 – News Release: Food regulators seize adulterated milk products for food safety violations. The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia. The company is owned by the Maryland and Virginia Milk Producers Cooperative Association Inc. in Reston, Virginia. The seized products include dry nonfat milk powder and buttermilk powder packaged in 40- and 50-pound bags for further manufacturing and are worth nearly $4 million.
Press Office Contact: Megan McSeveney, 240-402-4514,
Wednesday, 11/30 – FDA Voice Blog: Trade Alert: FDA Issues New Import Data Requirements. One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015.
Press Office Contact: FDA Office of Media Affairs, 301-796-4540,


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Media Inquiries: FDA Office of Media Affairs, 301-796-4540,
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Page Last Updated: 12/05/2016
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