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30 Oct 2022, 3:50 am by Tom Sharbaugh
” Emily Esfahani Smith & Roy BaumeisterAs a long-time veteran of Big Law myself, these questions haunted me. [read post]
29 Sep 2022, 9:06 pm by Jonan Pilet
”  In closing, Marler’s advice to the panel was to create separate commissioners in the FDA — one for food and one for drugs. [read post]
28 Sep 2022, 5:58 pm by Celeste Letourneau and John D. Kendzior
On September 27, 2022, FDA announced the publication of a  final guidance  document entitled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (Final CDS Guidance), which focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food Drug and Cosmetic Act. [read post]
30 Aug 2022, 1:20 pm by News Desk
The recall was the result of a routine sampling program conducted by the Food and Drug Administration, which revealed some finished products contained the bacteria. [read post]
19 Aug 2022, 9:05 pm by Elizabeth Yin
Food and Drug Administration (FDA) for approval to treat mental health disorders. [read post]
19 Aug 2022, 12:20 pm by John Ross
If so, you should be just as hopping mad as we are about the city of Denver's recent ban on food trucks in Lower Downtown. [read post]
12 Aug 2022, 6:34 am by Dan Bressler
Food and Drug Administration (FDA) announced that it would not issue new contracts with McKinsey & Company pending ongoing investigations into whether McKinsey failed to divulge potential conflicts of interest over its work with both the FDA and opioid manufacturers,’ Rubio’s office noted. [read post]
1 Jun 2022, 3:18 pm by News Desk
This recall is the result of routine sampling by the Food and Drug Administration, which revealed the presence of Listeria monocytogenes. [read post]
5 May 2022, 9:08 pm by Jillian Moss
” The Food and Drug Administration (FDA) announced that it would hold listening sessions to discuss two recently proposed regulations involving tobacco product standards. [read post]
2 May 2022, 9:01 pm by Austin Sarat
In the 20th century, they took on the role of producing medications for patients, institutions, and most recently, death penalty states on a case-by-case basis.However, unlike larger pharmaceutical companies, compounding pharmacies are not subject to extensive regulation by the Food and Drug Administration. [read post]
29 Apr 2022, 4:00 am by Jim Sedor
As the Food and Drug Administration considers a nationwide ban, the owner of the country’s most popular menthol brand has waged a huge lobbying and public relations campaign to keep them in the hands of smokers. [read post]
22 Apr 2022, 7:51 am by Robert Liles
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. [read post]
18 Apr 2022, 4:40 pm by Bill Marler
Food and Drug Administration announced that a culture of a sample of prepackaged Nestle Toll House refrigerated cookie dough currently under recall yielded E. coli O157:H7. [read post]
18 Apr 2022, 8:11 am by Dan Bressler
He was also helping the Food and Drug Administration overhaul its office that approves new drugs — the same office that would determine the regulatory fate of Purdue’s new line of proposed products. [read post]
This reference data includes medical device and medical supply name and Primary Device Identifier information for all the medical devices and medical supplies listed annually through December 31st in the Food and Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID). [read post]
13 Apr 2022, 4:30 am by Michael C. Dorf
If a Muslim or Jewish prisoner is entitled to Halal or Kosher food, then a conscientious but atheist vegan prisoner would likewise be entitled to vegan food. [read post]
7 Apr 2022, 9:04 am by Kevin Madagan and Matthew Loughran
The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. [read post]
19 Mar 2022, 2:09 pm by admin
Food and Drug Administration (FDA) with respect to mutagenic impurities in medications provides an illustrative example of how theoretical and hypothetical risk assessment can be.[6] The FDA’s risk assessment approach is set out in a “Guidance” document, which like all such FDA guidances, describes itself as containing non-binding recommendations, which do not preempt alternative approaches.[7] The agency’s goal is devise a control strategy for any mutagenic… [read post]