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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]
24 Jun 2015, 10:27 am
Food and Drug Administration has accepted the proposed brand name Invossa for TissueGene-C, the company’s proprietary product in development for treatment of osteoarthritis of the knee. [read post]
1 Dec 2013, 10:15 pm
Food and Drug Administration(FDA) does not require cosmetic testing on animals, it does allow a company to take whatever steps necessary to prove product safety. [read post]
11 Jul 2012, 7:02 am
On July 10, the Food and Drug Administration (FDA) released a proposed rule on medical device labeling. [read post]
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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as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]
21 Mar 2012, 2:25 pm
As reported by Scott Sunde at the Seattle PI, the warning comes following a Food and Drug Administration (FDA) inspection that found egg-laying hens at the farm had been eating feed contaminated with rodent feces. [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The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization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]
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]
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]
9 Sep 2006, 12:44 am
[JURIST] The US Food and Drug Administration (FDA) [official website] announced Friday that it was fining the American Red Cross [NGO website] $4.2 million [press release] for "failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products" that had prompted the recall of 12,000 units of blood between 2003 and 2005. [read post]
5 Dec 2007, 5:50 am
Food and Drug Administration will consider the panel's [Dec. 5]recommendation as it decides whether to approve Avastin for breast cancer. [read post]
29 Apr 2006, 5:37 pm
[JURIST] Lester Crawford [official profile], the embattled former head of the US Food and Drug Administration [official website] who stepped down [JURIST report] in September 2005 after only three months in office in the midst of a furor over the agency's refusal to authorize over-the-counter distribution of Plan B emergency contraceptives [product backgrounder], is under criminal investigation [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]
23 Feb 2022, 10:00 pm
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. [read post]
7 Apr 2017, 5:58 am
Food and Drug Administration has issued a huge recall of the company’s EpiPen and EpiPen Jr. over concerns that the emergency injectors could fail to activate because of a defective part. [read post]
28 Oct 2015, 1:39 pm
The Food and Drug Administration (FDA) issued draft guidance regarding the packaging of certain injectable medical products. [read post]
2 Dec 2007, 11:01 pm
Food and Drug Administration lacks the funding to keep up with scientific advances, according to FDA advisers. [read post]
14 Dec 2009, 5:07 am
The Food and Drug Administration is probing the use of CT scans at Glendale Adventist Medical Center and Providence St. [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]
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]
