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1 Feb 2018, 9:00 am by Michael H Cohen
Food and Drug Administration (FDA); (ii) exempt from FDA preapproval under the Dietary Supplement and Health Education Act (DSHEA); or (iii) a pharmaceutical compound not commercially available and, therefore, is also an investigation article subject to clinical investigation standards as discussed in paragraph (7) of this section. (3) Treatment Plan. [read post]
31 Jan 2018, 9:01 pm by Coral Beach
Food and Drug Administration — during the current administration or previous ones — rest assured that Gorny’s new job as senior science adviser for produce safety at FDA’s Center for Food Safety and Applied Nutrition is good news for anyone who eats fresh produce in the United States. [read post]
30 Jan 2018, 2:58 pm by Emily Theriault
For example, the Department of Health and Human Services Office of Inspector General has issued guidance on kickbacks and the Food and Drug Administration has issued guidance on procedures, compounding, and labelling. [read post]
29 Jan 2018, 9:00 pm by News Desk
Seafood companies in Alabama and Indonesia are on   warning from the Food and Drug Administration for serious violations of U.S. law, specifically the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. [read post]
29 Jan 2018, 2:17 pm by Law Offices of Robert Dixon
Since the year 2000, the United States Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors throughout the country. [read post]
27 Jan 2018, 6:32 am by Law Offices of Jeffrey S. Glassman
Food and Drug Administration (FDA), but they are not applying for approval under a new drug application. [read post]
26 Jan 2018, 5:21 pm by Bill Marler
Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella infections. [read post]
26 Jan 2018, 5:18 pm by Bill Marler
Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella Montevideo infections. [read post]
26 Jan 2018, 6:34 am by Robert Kraft
OIG pointed specifically to a lack of alphanumeric characters used to identify medical devices by make, model, and lot number, which it said “prevents [Medicare] from being able to fully understand and address the Medicare costs” related to the devices, and added that the missing information “impedes the ability of the [Food and Drug Administration] and [Medicare] to identify poorly performing devices as early as possible. [read post]
25 Jan 2018, 9:30 pm by Sarah Madigan
Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) sent warning letters to 15 companies marketing unapproved “opioid cessation products” with claims touting their capacity to treat opioid addiction and withdrawal. [read post]
25 Jan 2018, 9:14 pm by News Desk
“Following cooking preparation instructions on the labels of master cases or packages will effectively reduce the risk of exposure to this bacterium,” according to the NFFC recall notice posted on the Food and Drug Administration website. [read post]
25 Jan 2018, 9:00 pm by Coral Beach
Food and Drug Administration are continuing their testing and traceback efforts in hopes of finding out how the “leafy greens” were contaminated. [read post]
24 Jan 2018, 6:00 am by Robert Kraft
” The article adds that Food and Drug Administration Commissioner Scott Gottlieb, prior to his nomination, “advocated loosening the restrictions on off-label communications. [read post]
22 Jan 2018, 9:00 pm by News Desk
However, no other related product recalls have yet been posted by the Food and Drug Administration. [read post]
22 Jan 2018, 9:00 pm by Dan Flynn
Food and Drug Administration and state health departments are conducting traceback investigations, seeking further distribution information about Jimmy John’s sprouts. [read post]
Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. [read post]
22 Jan 2018, 6:55 am by Robert Kraft
HealthDay reported the Food and Drug Administration warned that whole body cryotherapy is not supported by evidence and poses a number of risks. [read post]