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23 Jun 2009, 12:24 am
[JURIST] US President Barack Obama [official website] on Monday signed into law the Family Smoking and Tobacco Prevention Act [HR 1256 text], which grants the Food and Drug Administration (FDA) [official website] certain authority to regulate tobacco 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]
24 Sep 2020, 4:15 am
Food and Drug Administration (FDA) and the biopharmaceutical industry. [read post]
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The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies.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]
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The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies.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]
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]
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]
3 Mar 2021, 3:23 pm
Earlier this week, the Food & Drug Administration announced a recall for certain taco products manufactured in St. [read post]
29 Dec 2020, 10:00 pm
Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. [read post]
26 Aug 2019, 7:27 am
A Rockville science and technology firm has expanded its team for a Food and Drug Administration contract. [read post]
5 Jun 2018, 4:53 pm
Food and Drug Administration issued a Monday alert over five deaths related to intragastric balloons. [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]
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]
13 Apr 2023, 10:00 pm
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still seriously hinder FDA’s authority with respect to how it regulates products and determines how and when it will interact with the life sciences industry—and the judicial process. [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]
13 Apr 2023, 10:00 pm
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still seriously hinder FDA’s authority with respect to how it regulates products and determines how and when it will interact with the life sciences industry—and the judicial process. [read post]
11 Mar 2011, 3:00 pm
What has really concerned California injury lawyers, are new allegations that the Food and Drug Administration was aware of these possibly contaminated alcohol swabs, but failed to act to remove these from market shelves. [read post]
3 Oct 2018, 2:58 pm
The Food and Drug Administration launched a surprise raid inspection on the headquarters of e-cigarette manufacturer Juul, hauling away hundreds of files related to the company’s sales and marketing tactics. [read post]
19 Oct 2022, 10:00 pm
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). [read post]
13 Jun 2011, 10:13 am
The Food and Drug Administration said Monday that federal prosecutors filed a legal injunction against the Triad Group and [...] [read post]
