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13 Aug 2015, 1:15 pm
Government Accountability Office (GAO), insisting that the group open an investigation with the Food and Drug Administration regarding the real dangers of power morcellators. [read post]
7 Nov 2011, 9:25 am
The Food and Drug Administration (FDA) [official website] has mandated that by September 2012, all cigarette packaging shall contain new warning labels [FDA backgrounder] with graphic images of the... [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]
14 Sep 2023, 10:00 pm
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). [read post]
30 Sep 2010, 4:29 pm
The investigation is based on complaints by Food and Drug Administration scientists, who say that they were pressured to approve some of these high-tech medical scanners in spite of evidence that they could cause harm to patients. [read post]
20 Feb 2023, 10:00 pm
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. [read post]
12 Sep 2021, 9:15 am
Food and Drug Administration (FDA). [read post]
28 May 2008, 4:40 am
Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. [read post]
12 Sep 2021, 9:15 am
Food and Drug Administration (FDA). [read post]
15 Jun 2005, 5:14 am
[JURIST] A Senate committee approved the nomination of Lester Crawford [official profile] as the new head of the US Food and Drug Administration [official site] on Wednesday, sending the issue to the full Senate for a final vote. [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]
4 May 2018, 2:15 am
Clayton has more than 10 years of experience guiding industry-leading companies through sophisticated patent litigation, as well as complex Food and Drug Administration regulatory matters. [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]
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]
4 Jun 2024, 6:52 am
The Food and Drug Administration is failing to deliver a clear and important message about e-cigarettes, particularly to adults who smoke and the physicians treating them. [read post]
14 Apr 2005, 9:06 am
[JURIST] A federal judge in Utah has struck down the Food and Drug Administration ban on the weight-loss supplement ephedra, pulled off the market by the FDA in April 2004 [FDA press release] after it was found to be linked to some 155 deaths. [read post]
24 Dec 2014, 8:11 am
[JURIST] The US Food and Drug Administration (FDA) on Tuesday announced [press release] a plan to end the practice of indefinitely banning men who have ever engaged in sexual acts with other men from donating blood. [read post]
9 Aug 2023, 10:00 pm
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). [read post]
16 Jul 2014, 10:35 am
FDA Investigates Potentially Dangerous Devices Used for Fibroid Surgery On July 11th, the Food and Drug Administration stated that they would create a panel to investigate the potential safety, and danger, of laparoscopic power morcellators (LPM’s), which have been called dangerous devices by patients who believe their fibroid surgery contributed to uterine cancer. [read post]
22 Jul 2010, 1:32 pm
., is the third Johnson & Johnson plant to be flagged this year by the Food and Drug Administration for serious manufacturing defects -- an unusual number for a single company. [read post]
