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3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
4 Apr 2022, 8:15 am
Food & Drug Administration’s recent agreements on medical device user... [read post]
21 Sep 2022, 2:59 pm
Members of Congress, as usual, are racing to meet a deadline: This time, to determine the funding for the federal Food and Drug Administration, an agency with some of the most consequential responsibilities affecting Americans’ health. [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]
22 Oct 2012, 2:27 pm
Food and Drug Administration. [read post]
17 Apr 2016, 11:05 am
Food and Drug Administration on Thursday explained how drugmakers can increase confidence in the integrity of their manufacturing data, a move that will not only help manufacturers but also eliminate excuses for inconsistent record-keeping and make penalties more likely, attorneys say.The post FDA Creates Data Integrity Guide to End Drugmakers’ Excuses appeared first on Legal Reader. [read post]
14 Dec 2011, 11:44 am
[JURIST] A judge for the US District Court for the Eastern District of New York [official website] on Tuesday revived a six-year-old lawsuit over the Plan B emergency contraceptive [product website], but declined to hold the Food and Drug Administration (FDA) [official website] in contempt. [read post]
16 Dec 2013, 11:38 am
Food and Drug Administration Friday night.The FDA's determination relates to a recall initiated by Medtronic last month of nearly 15,000 guidewires manufactured since April that are used in heart procedures. [read post]
19 Apr 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On April 12, 2016, the US Food and Drug Administration (FDA) issued warnings that targeted the allegedly substandard protection of research participants at a hospital in the Mayo Clinic Care Network. [read post]
4 Oct 2015, 10:16 am
Specifically, the lawsuit points to a Food and Drug Administration (FDA) [official website] warning... [read post]
11 Apr 2024, 10:00 pm
In an article written for Law360 , partners Rebecca Dandeker and Aliza Karetnick and associate Rachel Lamparelli discuss a citizen petition to the US Food and Drug Administration (FDA) and litigation tied to concerns about the presence of the chemical benzene in acne products containing benzoyl peroxide. [read post]
12 Jun 2009, 7:27 am
[JURIST] The US House of Representatives [official website] on Friday approved the Family Smoking Prevention and Tobacco Control Act [HR 1256 materials], which attempts to safeguard the public by granting the Food and Drug Administration (FDA) [official website] certain authority to regulate tobacco products, among other provisions. [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]
2 Aug 2021, 10:00 pm
Food and Drug Administration. [read post]
2 Aug 2021, 10:00 pm
Food and Drug Administration. [read post]
19 Oct 2010, 4:58 pm
In a surprising move, the US Food and Drug Administration has acknowledged that it had erroneously approved a knee implant device due to pressure from members of Congress from New Jersey. [read post]
15 Jul 2004, 1:28 pm
The amendment would give the Food and Drug Administration regulatory control over tobacco products and would buy out the quotas currently given to about 400,000 US farmers. [read post]
31 Aug 2005, 9:32 am
[JURIST] A high-level Food and Drug Administration [official website] official resigned Wednesday to protest the agency's delay in deciding whether to approve emergency contraception pills for over-the-counter sale. [read post]
17 Oct 2006, 12:12 pm
Crawford [official profile], former commissioner of the US Food and Drug Administration (FDA) [official website], pleaded guilty to charges [criminal information, PDF] of conflict of interest and false writing [US Code text] at his arraignment hearing Tuesday afternoon in front of US Magistrate Judge Deborah Robinson. [read post]
