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11 Jul 2012, 7:02 am
On July 10, the Food and Drug Administration (FDA) released a proposed rule on medical device labeling. [read post]
20 Sep 2017, 5:47 am
The Food and Drug Administration plans to launch a study with the intent of finding new warning labels for cigarette packs. [read post]
29 Dec 2020, 10:00 pm
Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. [read post]
5 May 2024, 10:00 pm
The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). [read post]
5 May 2024, 10:00 pm
The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). [read post]
17 Oct 2005, 1:13 pm
[JURIST] Susan Wood, former director of the US Food and Drug Administration's Department of Women's Health [official website] said Monday that the FDA's refusal earlier this year to consider over-the-counter sales of Plan B [FDA backgrounder], also known as the morning-after pill, was based on political considerations rather than scientific facts. [read post]
16 Dec 2020, 10:00 pm
On the heels of the US Food and Drug Administration’s first issuance of an Emergency Use Authorization for a coronavirus (COVID-19) vaccine, the Equal Employment Opportunity Commission published an updated technical assistance bulletin that begins to address some of the questions employers have raised regarding whether they can require employees to get vaccinated for COVID-19, as well as considerations employers should be aware of if they do offer a COVID-19… [read post]
27 Apr 2016, 6:31 pm
Food and Drug Administration (FDA) announced last week a proposal to ban electrical stimulation devices (ESDs), it was a long awaited final chapter in a lawsuit brought by Lubin & Meyer on behalf of Cheryl McCollins whose son Andre had been severely injured due to repeated electrical shock treatments while a student at the Judge Rotenberg Center. [read post]
11 Jan 2024, 10:00 pm
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
23 Oct 2012, 5:54 am
Food and Drug Administration for its non-invasive fetal heart rate monitor, MERIDIAN™. [read post]
31 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. [read post]
19 Oct 2022, 10:00 pm
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). [read post]
24 Aug 2012, 10:12 am
In a 2-1 decision, the DC Circuit struck down a Food and Drug Administration (FDA) [official website] regulation that requires tobacco companies to display graphic images such as a man smoking a cigarette through a hole in his throat. [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]
23 Apr 2016, 5:20 pm
Approval process for e-cigs changed by House committee vote on Tuesday that will exempt all electronic cigarettes and cigars currently on the market from the costly review process required by rules that are being finalized by the Food and Drug Administration (FDA). [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]
12 Jun 2010, 4:33 pm
Milk Pasteurization Controls and Tests, the Food and Drug Administration course manual for training their inspectors, will be used in this course. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
12 Jan 2018, 11:21 am
The Food and Drug Administration granted clearance last month to the GammaPod, a device that could cut the number of radiation sessions breast cancer patients need and possibly even eliminate ... [read post]
