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27 Feb 2011, 11:55 am
[JURIST] Two tobacco companies filed a lawsuit [press release] in the US District Court for the District of Columbia [official website] on Friday against the Food and Drug Administration (FDA) [official website] in order to enjoin a recent opinion by the agency's advisory committee due to conflicts of interest. [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]
16 May 2024, 10:36 am
Food and Drug Administration (FDA), and the U.S. [read post]
8 Feb 2023, 9:12 am
Our office is investigating these, 813-278-7772Pharmaceutical company Global Pharma Healthcare has recalled its over-the-counter artificial teardrops over possible contamination after the Food and Drug Administration urged consumers to immediately stop using the product. [read post]
17 Jan 2022, 10:00 pm
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. [read post]
24 Aug 2016, 8:53 am
Food and Drug Administration (FDA) de novo clearance. [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]
20 Jan 2021, 10:00 pm
Related to potential home-testing options, our FDA team has published a LawFlash on the Food and Drug Administration’s (FDA’s) Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home, the first OTC home sample collection kit for COVID-19 testing, and additional prescription at-home tests and sample collection kits. [read post]
8 Sep 2014, 11:33 am
FDA Fails to Find Evidence That Use of Testosterone Therapy Works The Food and Drug Administration has scheduled a meeting amongst regulators to discuss the benefits and detriments of the use of testosterone therapy, in light of numerous Low T personal injury lawsuits that have recently alleged harmful side effects from using the product, including blood […] [read post]
1 May 2009, 11:17 am
Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Lovate Health Sciences USA Inc. of Blasdell, N.Y. [read post]
20 Oct 2011, 6:09 am
MBBP client Pluromed, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved their surgical gel, LeGoo® Internal Vessel Occluder. [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]
6 May 2009, 4:49 pm
Food and Drug Administration on April 24. [read post]
17 Jan 2022, 10:00 pm
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. [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]
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 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]
3 Mar 2019, 9:15 am
Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. [read post]
8 Mar 2016, 8:02 pm
Food and Drug Administration reported possible listeria monocytogenes. [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]
