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22 Apr 2021, 10:00 pm
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators. [read post]
22 Apr 2021, 10:00 pm
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators. [read post]
13 May 2009, 9:25 am
Food and Drug Administration is taking issue with claims that Cheerios cereal can lower cholesterol. [read post]
22 Nov 2006, 6:28 am
Anna Wilde Mathews, who covers the Food and Drug Administration for The Wall Street Journal, filed this dispatch late yesterday with the Law Blog: In a victory for the FDA, the D.C. [read post]
27 Mar 2008, 12:07 pm
Here's an excerpt: The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices... [read post]
25 Feb 2004, 1:50 pm
The Pioneer Press reports today that Minnesota will continue to operate its prescription drug website despite written warnings by the Food and Drug Administration that it illegally encourages Minnesotans to buy Canadian medicines. [read post]
28 Sep 2016, 9:06 am
Yesterday, the Food and Drug Administration (“FDA”) announced guidance regarding using the term “healthy” in the labeling of human food products. [read post]
28 Sep 2016, 9:06 am
Yesterday, the Food and Drug Administration (“FDA”) announced guidance regarding using the term “healthy” in the labeling of human food products. [read post]
30 Jul 2012, 2:59 am
Food and Drug Administration is seeking comments on a proposal to make changes to the reporting requirements for antimicrobial sales and distribution. [read post]
8 Dec 2017, 12:45 pm
Food and Drug Administration recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to manage the metabolic processes associated with osteoarthritis. [read post]
12 Apr 2010, 4:12 am
The Food and Drug Administration has proposed to amend its regulations concerning direct-to- consumer (DTC) advertisements of prescription drugs. [read post]
23 May 2010, 8:49 pm
Kirschenbaum - The Obama Administration took two steps on Friday to advance the implementation of health care reform, both of which are of interest to drug manufacturers. [read post]
3 Dec 2009, 3:08 pm
Food and Drug Administration ("FDA") has announced that patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances should take Norpramin only with extreme caution. [read post]
3 Apr 2017, 10:00 pm
Food and Drug Administration-approved treatment for food allergy is yet available. [read post]
10 Aug 2007, 7:53 am
"The Abigail Alliance, an organization for terminally ill patients and their families, sought to expand access to "experimental drugs," approaching the Food & Drug Administration with an administrative petition back in the summer of 2003, and on several occasions after that, each of which was rejected.Abigail then filed suit in D.C. [read post]
18 Apr 2012, 8:46 am
April 17, 2012), 2012 WL 1288732: When the Food and Drug Administration (FDA) evaluates an application to... [read post]
3 Jan 2023, 7:56 pm
The US Food and Drug Administration (FDA) Tuesday announced that it will allow Mifepristone, a drug used during a medication abortion, to be dispensed by certified retail pharmacies. [read post]
16 Jun 2015, 2:57 pm
DEPARTMENT OF HEALTH AND HUMAN SERVICES – Food and Drug Administration [Docket No. [read post]
5 Dec 2016, 2:20 pm
The federal Food and Drug Administration, which won’t comment on the matter, has approved Phase 3 clinical trials (large-scale human research) of MDMA for treatment of PTSD, according to Multidisciplinary Association for Psychedelic Studies (MAPS). [read post]
27 Jan 2022, 9:05 pm
“The Food and Drug Administration must heed EFSA’s warnings and take immediate and decisive action to lower our exposures to this dangerous chemical. [read post]
