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12 Dec 2018, 7:30 am
Another recall related to dog food was recently issued, adding to the growing list of dog food brands affected by elevated levels of vitamin D, according to the Food and Drug Administration. [read post]
12 Dec 2018, 6:40 am
We are working closely with the manufacturer, MDARD, and the Food and Drug Administration (FDA) to understand the cause of the situation and ensure that all affected product has been pulled from commerce. [read post]
12 Dec 2018, 6:37 am
’” The New York Times reports the decision by Juul Labs, which has more than 70 percent of the US e-cigarette market, “was made as the Food and Drug Administration moved forward with a plan to ban sales of flavored e-cigarettes in convenience stores and gas stations. [read post]
11 Dec 2018, 9:05 pm
A past farm bill moved catfish inspections to USDA from the Food and Drug Administration (FDA). [read post]
10 Dec 2018, 9:00 pm
Smucker’s officials initiated the recall, which is being carried out in cooperation with the Food and Drug Administration, after internal finished product testing revealed the potential problem. [read post]
10 Dec 2018, 7:04 pm
The goal was to allow individuals with imminently life-threatening diseases or conditions to seek access to investigational drugs without the step of procuring permission from the Food and Drug Administration (FDA). [read post]
9 Dec 2018, 9:05 pm
Contributed My name is Scott Loughan and I am a Compliance Officer in the Food and Drug Administration’s Office of Regulatory Affairs. [read post]
9 Dec 2018, 9:03 pm
The Food and Drug Administration recently warned owners of a beef producer, a dairy, and a frozen food company about violations of federal food safety laws. [read post]
7 Dec 2018, 11:18 am
On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective safety and performance criteria, at least for certain well-known devices. [read post]
6 Dec 2018, 10:58 pm
Food and Drug Administration, Centers for Disease Control and Prevention, and the Public Health Agency of Canada (PHAC), continued to warn the public and businesses against eating or selling romaine unless they know for sure it is not from previously specified regions of California. [read post]
6 Dec 2018, 9:30 pm
Food and Drug Administration (FDA) recognized a public genetic database as “a source of valid scientific evidence. [read post]
6 Dec 2018, 9:03 pm
Some details from a Kentucky candy maker and the Food and Drug Administration don’t quite match up, but the federal agency and the operator of Bauer’s Candies agree there is a chance some of the company’s products are contaminated with the hepatitis A virus. [read post]
6 Dec 2018, 9:00 pm
On Dec. 3, the Food and Drug Administration issued a public alert about the potential for elevated vitamin D levels in several brands of dry pet foods produced by “a common contract manufacturer. [read post]
6 Dec 2018, 3:53 am
Food and Drug Administration (FDA) as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. [read post]
5 Dec 2018, 9:00 pm
The recall was initiated after routine testing by the Washington State Department of Agriculture revealed the presence of Listeria monocytogenes in a package of the pet food, and is being carried out with the knowledge of the Food and Drug Administration. [read post]
5 Dec 2018, 2:15 pm
Campie, the justices have been asked to decide whether an FCA lawsuit can go forward when the government continues to pay for a product – here, drugs used to treat HIV – even after it learns about allegations that manufacturers had made false statements to the Food and Drug Administration about where it would produce the active ingredients in the drugs. [read post]
5 Dec 2018, 7:27 am
Those include a review of information security programs of Medicare contractors, a review of HHS’ compliance with the Federal Information Security Modernization Act of 2014, a report spotlighting the need for the Centers for Medicare & Medicaid Services to enhance the resiliency of its systems, and a report urging the Food and Drug Administration to “further investigate” cybersecurity reviews in its pre-market approval process for medical devices. [read post]
4 Dec 2018, 9:05 pm
Food and Drug Administration (FDA) did only limited testing and didn’t confirm the connection. [read post]
4 Dec 2018, 9:04 pm
Food and Drug Administration (FDA) advised consumers not to eat Achva, Achdut, Soom, S&F, Pepperwood, and Baron’s brand tahini. [read post]
4 Dec 2018, 8:04 am
FDA Commissioner Scott Gottlieb If the federal Food and Drug Administration expected any public goodwill for putting forward long-term proposals to change a fundamental way that medical devices win agency clearance, forget about it. [read post]
