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10 Apr 2023, 6:33 am
This week, FOIAengine takes a look at some who are bombarding the Food and Drug Administration and other federal agencies with Freedom of Information Act document demands about Pfizer and Moderna. [read post]
20 Jun 2024, 10:00 pm
Last year, the US Food and Drug Administration (FDA) announced that it would delay enforcement of certain requirements under the Modernization of Cosmetics Regulation Act (MoCRA) until July 1, 2024 to give the industry more time to comply with pending deadlines. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [read post]
16 Oct 2009, 6:53 pm
Food and Drug Administration refused 13 shipments of Canadian canola meal that contained salmonella in August and September, all from plants owned by Bunge Ltd., the FDA's website showed. [read post]
27 Jan 2021, 10:00 pm
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [read post]
23 Feb 2022, 10:00 pm
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. [read post]
2 Mar 2023, 10:00 pm
Partners Michele Buenafe, Jacob Harper, and Andrew Gray wrote the first of a two-part article series for Med Device Online, covering the existing US Food and Drug Administration (FDA) programs, recently issued guidance impacting artificial intelligence and machine learning technologies intended for use in healthcare, and what to expect from the FDA’s FY 2023 priority list. [read post]
14 May 2015, 1:12 pm
[JURIST] The Food and Drug Administration (FDA) [official website] on Tuesday released a set of proposed guidelines [text, PDF] outlining a plan to end the national lifetime ban on blood donations from homosexual individuals. [read post]
13 Apr 2023, 10:00 pm
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still seriously hinder FDA’s authority with respect to how it regulates products and determines how and when it will interact with the life sciences industry—and the judicial process. [read post]
17 Feb 2023, 12:58 pm
The Centers For Disease Control and the Food and Drug Administration have also advised that consumers and clinicians immediately stop using Delsam Pharma’s […] The post Eye Drops Linked To Vision Loss and Death appeared first on Panter, Panter & Sampedro. [read post]
22 Jul 2004, 1:35 pm
Ellis were indicted Thursday on federal charges of lying to the Food and Drug Administration about its diet supplement containing the now-banned herbal stimulant ephedra. [read post]
24 Jul 2007, 1:36 pm
Mark McClellan [official profile] said Tuesday that the US Food and Drug Administration [official website] is currently unable to handle the responsibility of tobacco regulation. [read post]
29 Feb 2008, 11:24 am
The military personnel had challenged a finding by the Food and Drug Administration (FDA) [official website] that the vaccine was safe, but Judge Rosemary [read post]
15 Feb 2008, 2:56 pm
Food and Drug Administration officials (FDA) stated yesterday that it received reports of at least one death among patients who received botox injections as well as a "a relative handful" of serious side effects in which the toxin spread beyond the injection site. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
5 Aug 2010, 4:42 pm
This week, the US Food and Drug Administration released a set of proposed changes to the medical device approval process, specifically its 501 (k) fast-track approval system. [read post]
28 Apr 2017, 11:30 am
” Under Barack Obama, the Food and Drug Administration began classifying e-cigarettes as tobacco products. [read post]
10 Dec 2020, 3:05 pm
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as ... [read post]
