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29 Apr 2022, 10:55 am
The Food and Drug Administration set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children. [read post]
4 Mar 2022, 7:04 pm
Earlier this week, the Food and Drug Administration (FDA) issued a recall for certain Brut and Sure deodorants. [read post]
29 Jan 2008, 4:47 pm
Here's an excerpt: The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure... [read post]
20 Jul 2020, 10:00 pm
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices. [read post]
28 Dec 2020, 10:00 pm
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing 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]
23 Jul 2013, 8:10 pm
The Boston Globe: Plan B One-Step gets exclusive rights, by Deborah Kotz: The US Food and Drug Administration decided late Monday night to grant exclusive rights to Teva Pharmaceuticals to put its brand name form of emergency contraception on drugstore... [read post]
5 Jul 2020, 10:00 pm
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [read post]
23 Jan 2009, 9:13 am
The Government Accountability Office (GAO) recently issued a report indicating that the Food and Drug Administration (FDA) is sending Class III medical devices to market with minimal review. [read post]
8 Jun 2009, 4:19 pm
Here's an excerpt: Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco... [read post]
20 Jul 2009, 5:32 pm
Food and Drug Administration... [read post]
25 Sep 2015, 7:41 am
., Board Certified by The Florida Bar in Health Law In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration … Continue reading → [read post]
20 Jan 2019, 9:00 pm
The ongoing partial shutdown of the federal government is having a wide range of impacts, from reportedly slowing lines at airports around the country to stifling food and drug inspectors. [read post]
5 Aug 2014, 6:22 am
Most recently, on July 31, pursuant to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA... [read post]
16 Jan 2009, 12:03 pm
The New York Times reports that the Government Accountability Office recently criticized the Food and Drug Administration's device approval process. [read post]
15 Feb 2022, 10:00 pm
Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. [read post]
27 Sep 2007, 2:53 am
AEI's Scott Gottlieb, the former FDA commissioner, writes in the Wall Street Journal:Democrats staged an 11th-hour showdown this week over a bill that funds the Food and Drug Administration (FDA). [read post]
18 Nov 2017, 10:03 am
January 19 is the deadline to comment on a petition asking the Food and Drug Administration (FDA) to exempt over-the-counter (OTC) denture repair kits from the premarket notification requirements. [read post]
14 Sep 2023, 10:00 pm
Gucciardo , who counsels medical device manufacturers throughout the product lifecycle in the US Food and Drug Administration (FDA) regulatory context, shares insight into some important considerations when creating, reviewing, and implementing medical device product warranties. [read post]
16 Jun 2016, 12:24 am
., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data … Continue reading → [read post]
