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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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as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]
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]
19 Apr 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On April 12, 2016, the US Food and Drug Administration (FDA) issued warnings that targeted the allegedly substandard protection of research participants at a hospital in the Mayo Clinic Care Network. [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]
6 Apr 2017, 6:30 am
Nominated as the head of the Food and Drug Administration, Gottlieb is a practicing physician who ran an office within the FDA during the Bush presidency. [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 Apr 2023, 10:00 pm
They cover how although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the US Food and Drug Administration's (FDA) approval of a commonly used abortion medication, several points made by the courts are worth considering for their potential effect on FDA authority and the challenges they may create for the life sciences industry. [read post]
5 Jun 2019, 8:25 am
Food and Drug Administration Wednesday granted premarket approval to Baltimore-based DT MedTech LLC for its Hintermann Series H3 Total Ankle Replacement System. [read post]
26 Feb 2024, 10:10 am
Recently, a group of U.S. senators called for a thorough investigation into the oversight practices of the Food and Drug Administration (FDA) regarding medical devices. [read post]
3 Aug 2022, 4:40 am
Lewis bring federal ADR experience from the Food and Drug Administration, where he has been a conflict resolution specialist in Maryland. [read post]
16 May 2018, 4:15 am
Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. [read post]
30 Sep 2013, 9:00 am
Food and Drug Administration (FDA) issued final guidance governing the development of mobile medical apps. [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]
1 Feb 2021, 10:00 pm
Members of our vaccine taskforce recently published an important Insight outlining a selection of key legal considerations and updates as the COVID-19 vaccine rollout continues to take shape, including the status of the US Food and Drug Administration’s vaccine products, distribution, key legal issues at the state level, employer mandates and employee incentives, and important liability concerns. [read post]
13 Jun 2006, 9:06 am
[JURIST] A former commissioner of the US Food and Drug Administration [official website] testified in a deposition [text, PDF] that the agency postponed a decision to allow over-the-counter sales of Plan B emergency contraceptives [product backgrounder] while it considered how to restrict nonprescription access only to females 17 and older. [read post]
16 Feb 2007, 3:18 am
[JURIST] A group of lawmakers from the US Senate and House of Representatives on Thursday introduced [press release] the Family Smoking Prevention and Tobacco Control Act [S 2461 text; PDF], which would give the Food and Drug Administration (FDA) [official website] the same authority to regulate tobacco products as it has over other consumer products. [read post]
23 Oct 2012, 12:25 pm
On Monday, the Food and Drug Administration announced that it would investigate five deaths that have been linked to the energy drink.According to Reuters,read more [read post]
2 May 2021, 10:00 pm
Despite having authority to issues such notices since the 2007 passage of the Food and Drug Administration Amendments Act (FDAAA), FDA has not previously exercised its clinicaltrials.gov enforcement authority. [read post]
19 Nov 2021, 8:07 am
Food and Drug Administration to approve booster doses of the Pfizer and Moderna vaccines for adults. [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]
