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8 Jan 2017, 10:13 pm by News Desk
Photo by Dreamstime In a warning letter dated Sept. 15, 2016, and recently made public, the Food and Drug Administration threatened to seize products and/or seek an injunction against Walid Abdul-Wahab and his Santa Monica-based Desert Farms company. [read post]
8 Jan 2017, 10:00 pm by News Desk
Three warning letters recently posted by the Food and Drug Administration cited food safety violations at a tofu production plant in California, a supplement company in Nebraska and a supplier of fish roe based in Peru. [read post]
8 Jan 2017, 10:00 pm by Laura Mushrush
Food recall surgeAccording to Stericycle Expert Solutions Recall Index, the Food and Drug Administration had a 34 percent uptick in recalls from the second quarter of 2016 to the third quarter, making Q3 the highest recall period since the first quarter of 2010. [read post]
6 Jan 2017, 10:46 am by Patrick A. Malone
The federal Food and Drug Administration has written to caregivers nationwide with a new caution that, within the last three years, it has received a dozen reports of “smoke, fire, melting batteries, burning, and other hazards” with medical carts. [read post]
Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. [read post]
6 Jan 2017, 6:56 am by Leav & Steinberg, L.L.P.
Food and Drug Administration and the Centers for Disease Control have expressed concern about e- cigarettes’ safety for the user and non-user, samples having tested positive for carcinogens, as well as the concern that they may lead to the use of other nicotine products by young people (see https://www.cdc.gov/tobacco/stateandcommunity/pdfs/cdc-osh-information-on-e-cigarettes-november-2015.pdf; https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm506676.htm#safer… [read post]
5 Jan 2017, 10:01 pm by Coral Beach
The Food and Drug Administration’s deadline for public comments on the topic is now April 26, which is a month longer than at least one extension request sought. [read post]
Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. [read post]
The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused it’s end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. [read post]
5 Jan 2017, 7:15 am by Robert Kraft
The AP reports that the Food and Drug Administration warned Tuesday that common anti-diarrhea drugs, such as prescription Imodium (loperamide) and related over-the-counter drugs, “can cause potentially deadly heart problems when taken at higher-than-recommended levels. [read post]
4 Jan 2017, 10:00 pm by News Desk
Known in the animal pharmaceutical industry as GFI #213, the Food and Drug Administration began the process of implementing the guidance in 2013. [read post]
4 Jan 2017, 7:09 pm by Schachtman
What gave the trial judge his argument for ignoring the “specific methodology” used by scientists, the Daubert factors, and indeed any and all factors for assessing the validity of a scientific claim and conclusion, was the language used by the Food and Drug Administration (FDA) and GSK, the NDA-holder, in various communications. [read post]
4 Jan 2017, 4:37 pm by Sabrina I. Pacifici
Pew Charitable Trusts: “The Food and Drug Administration announced an important milestone today in efforts to ensure that antibiotics are used responsibly in food animals. [read post]
4 Jan 2017, 8:39 am by Rachel Gerber
[JURIST] Texas [official website] filed a lawsuit [complaint, PDF] Tuesday against the Food and Drug Administration [official website] to force it to decide whether an impounded shipment of a drug used for executions should be delivered to the Texas prison system, which has carried out more lethal injections than any other state. [read post]
4 Jan 2017, 6:36 am by Robert Kraft
” TIME reports COX-2 inhibitors “seemed especially risky for the heart, leading to the withdrawal from the market of one medication and a Food and Drug Administration warning on others. [read post]