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1 Aug 2006, 7:07 am
[JURIST] Democratic senators criticized the acting director of the US Food and Drug Administration [official website] Tuesday for the timing of the agency's announcement that it would reconsider allowing some over-the-counter sales of emergency contraception. [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]
22 Jun 2009, 11:48 am
Food and Drug Administration. [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]
15 Oct 2004, 3:49 am
The Food and Drug Administration issued a Public Health Advisory Friday with new labeling requirements aimed at warning the public about increased risks of suicidal thoughts and behavior in children treated with antidepressants. [read post]
22 Dec 2010, 7:28 pm
Food and Drug Administration announced Tuesday. [read post]
20 Jan 2021, 10:00 pm
Related to potential home-testing options, our FDA team has published a LawFlash on the Food and Drug Administration’s (FDA’s) Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home, the first OTC home sample collection kit for COVID-19 testing, and additional prescription at-home tests and sample collection kits. [read post]
27 Jan 2021, 10:00 pm
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. [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for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance.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]
29 Jan 2022, 1:03 pm
The Food and Drug Administration has issued a warning about the potential health risks associated with Zantac. [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]
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]
20 Jan 2021, 10:00 pm
Related to potential home-testing options, our FDA team has published a LawFlash on the Food and Drug Administration’s (FDA’s) Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home, the first OTC home sample collection kit for COVID-19 testing, and additional prescription at-home tests and sample collection kits. [read post]
1 Aug 2007, 10:32 am
[JURIST] The US Senate Health, Education, Labor and Pensions Committee [official website] approved a bill Wednesday to allow the Food and Drug Administration (FDA) [official website] to regulate tobacco. [read post]
9 Nov 2023, 9:15 am
Food and Drug Administration’s (FDA) Orange Book. [read post]
2 Aug 2021, 10:00 pm
Food and Drug Administration. [read post]
29 Jan 2014, 11:29 am
As mentioned on our Health Industry Washington Watch blog, the Food and Drug Administration issued a final guidance document on January 16, 2014 which provides specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. [read post]
31 Oct 2010, 12:29 pm
The federal Food & Drug Administration has announced a nationwide recall of seven lots of Heparin injaction products at the healthcare provider level due to the presence of of oversulfated chondroitin sulfate contaminate.Posted by Louisville, Kentucky lawyer Larry Jones. [read post]
29 Aug 2016, 4:30 am
Food and Drug Administration (FDA) rejected Teva’s application to bring its competitive autoinjector to patients... [read post]
29 Jul 2014, 12:08 pm
By: David Fazzolare & Joanna Brougher Sandoz, a Novartis Group company, announced on July 24, 2014 that the US Food and Drug Administration (FDA) has accepted for review its application for a biosimilar version of filgrastim. [read post]
