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4 Feb 2019, 9:03 pm by News Desk
The Food and Drug Administration recently made public two warning letters issued in November 2018 involving significant violations of federal law. [read post]
3 Feb 2019, 9:00 pm
The pending and still tentative resolution of jurisdictional issues between the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) surrounding cell-cultured meat and poultry products should address one of the three core regulatory issues confronting this emerging industry. [read post]
1 Feb 2019, 9:00 am by Michael H Cohen
Also where FDA regulates certain claims for OTC drugs, these are considered drug claims. [read post]
31 Jan 2019, 8:32 am
In early 2000, Helsinn submitted protocols for Phase III clinical trials to the Food and Drug Administration (FDA), proposing to study a 0.25 mg and a 0.75 mg dose of palonosetron. [read post]
31 Jan 2019, 1:01 am by Phyllis Entis
Food and Drug Administration (FDA) cautioned pet owners not to feed one lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs pet food to their pets after the agency found Salmonella and Listeria monocytogenes in samples of the product. [read post]
30 Jan 2019, 2:35 pm by Cannabis Law Group
Food and Drug Administration, other businesses that profit from marijuana – even if they don’t have any part of growing or selling it – technically violate federal law. [read post]
29 Jan 2019, 9:56 pm by Coral Beach
The expanded recall covers all nut butters produced by Oskri — including butters made from seeds — according to a notice posted on the Food and Drug Administration’s website. [read post]
29 Jan 2019, 4:02 pm by Scott Bomboy
On January 28, 2019, the Food & Drug Administration ended a public comment period asking consumers for their opinions about plant-based food products that use language usually attributed to dairy products. [read post]
29 Jan 2019, 12:41 pm by Deborah Heller
For instance, the Food and Drug Administration (FDA) will begin once again accepting new drug and medical device applications. [read post]
29 Jan 2019, 9:53 am by bcutterlaw
Food and Drug Administration (FDA) proposed restrictions for e-cigarettes and called on makers of the devices to actively take measures to prevent youths from vaping. [read post]
29 Jan 2019, 6:58 am by Rachael G. Pontikes and Kelly Kearney
In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities entitled, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry,” (the Revised… [read post]
29 Jan 2019, 1:02 am by Steve Lubet
” Only if you search for the asterisk at the bottom of Boiron’s webpage will you learn that “these ‘uses’ have not been evaluated by the Food and Drug Administration. [read post]
28 Jan 2019, 9:57 am by Patrick A. Malone
The federal Food and Drug Administration in mid-February will convene its expert panel on women’s reproductive surgeries to see advice on next steps in what has become a legal and medical morass over transvaginal mesh operations. [read post]
28 Jan 2019, 6:51 am by Law Offices of Jeffrey S. Glassman
Food and Drug Administration is derelict in its duty to protect the public, perhaps it’s the news this week that Sri Lanka is the latest nation to ban import of Johnson and Johnson’s baby powder, amid growing proof of asbestos contamination. [read post]
27 Jan 2019, 9:05 pm by News Desk
To view the product photographs the company submitted to the Food and Drug Administration, please click here. [read post]