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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]
14 Dec 2011, 1:37 pm
Earlier this month, the Department of Health and Human Services in a memorandum blocked a Food and Drug Administration recommendation to make Plan B available without a prescription to women under 17. [read post]
26 Oct 2021, 10:00 pm
The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. [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]
11 Jun 2010, 7:59 am
Now the Food and Drug Administration has announced it is investigating hundreds of side effects, including fatalities, related to the recalls. [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]
4 Feb 2021, 9:15 am
Daewoong recently received Food and Drug Administration (FDA) approval to market an injection in the United States that competes with Botox, owned by Allergan-Medytox. [read post]
16 Nov 2016, 9:00 am
., Board Certified by The Florida Bar in Health Law A lung cancer vaccine that was developed in Havana, Cuba, will be the first such clinical trial to be approved by The Food and Drug Administration (FDA) for testing in the United States. [read post]
29 Apr 2019, 1:22 pm
Food and Drug Administration granted the company 510(k) clearance for its PUMA-G System April 10, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. [read post]
15 Jun 2016, 11:34 am
Food and Drug Administration’s efforts to protect consumers from pure powdered caffeine have been “sorely inadequate” as they have have allowed the sale of the dangerous substance to continue, said a watchdog group in a letter released on Friday. [read post]
22 Oct 2007, 9:30 am
Today a panel of the Food and Drug Administration (FDA) advised that over the counter medications for coughs and cold should not be taken by children younger than 6. [read post]
22 Apr 2019, 9:02 am
Food and Drug Administration (FDA) ordered two manufacturers of three different vaginal mesh products to immediately stop selling and distributing their products for not meeting U.S. premarket standards for high risk devices. [read post]
18 Jan 2024, 10:39 am
Food and Drug Administration regarding the device’s intended use. [read post]
9 Jul 2004, 7:20 am
The US Food and Drug Administration banned Friday the use of certain cow parts in cosmetic and dietary supplements to protect against mad cow disease. [read post]
22 Jun 2009, 6:01 pm
Food and Drug Administration (FDA) cautioned consumers that use of Zicam can result in the loss of sense of smell. [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]
15 Nov 2010, 4:33 pm
The Food and Drug Administration has cleared General Electric Co., and Toshiba Corp. from involvement in hundreds of cases of radiation overexposure that occurred in several hospitals, including those in Los Angeles. [read post]
31 Aug 2006, 8:47 am
The United States Food and Drug Administration has alerted the medical community and its patients of a potentially serious over infusion problem associated with the "Key Bounce" infusion pump. [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 Jun 2024, 10:00 pm
Last year, the US Food and Drug Administration (FDA) announced that it would delay enforcement of certain requirements under the Modernization of Cosmetics Regulation Act (MoCRA) until July 1, 2024 to give the industry more time to comply with pending deadlines. [read post]
