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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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as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]
2 Apr 2008, 12:27 pm
[JURIST] The US House Energy and Commerce Committee [official website] Wednesday voted 38-12 to approve the Family Smoking Prevention and Tobacco Control Act [HR 1108 text and amendment, PDF; JURIST report], a bill that would give the Food and Drug Administration (FDA) regulatory power over tobacco products. [read post]
13 Feb 2004, 9:16 am
The Food and Drug Administration has postponed a decision that was to be made next week on whether the so-called "morning after" pill for emergency contraception should be sold over the counter without a prescription. [read post]
13 Jan 2021, 12:08 pm
Food and Drug Administration has approved two for emergency use. [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]
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The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what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]
25 Jun 2007, 1:47 pm
Medtronic (06-179) [docket; cert. petition] the court will decide whether Food and Drug Administration (FDA) [official website] regulation of medical devices protects manufacturers, such as Medtronic, Inc. [read post]
14 Jan 2011, 1:53 pm
According to the Food and Drug Administration notice, the products are packaged in clear plastic bags and come with a label sticker that contains the name of the product as well as the UPC code. [read post]
23 Jan 2007, 4:55 pm
[JURIST] The US District Court for the District of Columbia [official website] Tuesday postponed the scheduled sentencing of former US Food and Drug Administration (FDA) [official website] commissioner Dr. [read post]
2 Dec 2007, 7:57 pm
Some interesting stuff in the Health Lawyers Weekly this time around: Top StoriesOIG Takes Back Power To Investigate Employee Criminal Conduct From FDA -- The Department of Health and Human Services Office of Inspector General (OIG) will no longer share responsibility with the Food and Drug Administration (FDA) for investigating potential criminal misconduct by FDA employees, Inspector General [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]
25 Dec 2011, 10:24 am
[JURIST] A group of Attorneys General representing 24 US states and territories filed an amicus brief with the US Court of Appeals for the District of Columbia Circuit [official website] on Friday arguing that the Food and Drug Administration (FDA) [official website] can require cigarette packages to display graphic images of the dangers of smoking. [read post]
3 Sep 2024, 1:00 pm
Food and Drug Administration for active immunization to prevent COVID-19 in individuals aged 12 and older. [read post]
1 Sep 2022, 2:42 pm
With the Food and Drug Administration authorizing new booster shots for emergency use, Maryland and other states must now decide how they plan to roll out the vaccine. [read post]
15 Jan 2023, 7:20 pm
Food and Drug Administration (FDA) will be holding a joint public listening session regarding areas for collaboration and engagement between the agencies. [read post]
17 Jan 2023, 4:15 am
Food & Drug Administration collaboration on Thursday; a panel discussion at the American Enterprise Institute about the near-term future for financial markets; and a discussion with IP experts at the USPTO about IP protection in China. [read post]
4 Jan 2024, 10:00 pm
The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration (FDA), recently issued a policy statement describing how the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits “unfair methods of competition. [read post]
20 Jul 2016, 2:05 pm
Food and Drug Administration thanks to new investments from the Maryland Technology Development Corp. [read post]
26 Apr 2017, 4:48 am
BOSTON — A group of U.S. senators led by Elizabeth Warren is pushing President Donald Trump’s nominee to head the Food and Drug Administration, which is headquartered in Silver Spring, for more information on how he plans to staff the agency. [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]
