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12 Dec 2023, 2:47 pm
The Food and Drug Administration is inspecting the Austrofoods facility located in Ecuador. [read post]
12 Dec 2023, 2:00 pm
Food and Drug Administration advises consumers not to eat restaurants and food retailers, not to sell, and to dispose of certain Red’s Best chopped clams. [read post]
11 Dec 2023, 8:33 pm
Using FDA’s per-lab number of tests, the number of LDTs would be well over 100,000. [read post]
11 Dec 2023, 12:57 pm
Food and Drug Administration’s (FDA) regular approval process. [read post]
11 Dec 2023, 12:41 pm
The Food and Drug Administration’s recent focus on the potential quality issues of plastic syringes manufactured in China has sent ripples through the healthcare and legal communities. [read post]
11 Dec 2023, 12:04 pm
The legislation is aimed at helping alleviate worker shortages at such facilities. ( BRIDGE MICHIGAN , LEXISNEXIS STATE NET) FDA Approves First CRISPR-Based Medicine The Food and Drug Administration approved the world’s first medicine based on CRISPR gene-editing technology. [read post]
11 Dec 2023, 10:36 am
According to Food and Drug Administration guidelines, patients should take PPIs over 14 days up to three times a year. [read post]
11 Dec 2023, 9:35 am
The DOJ also alleges that Berman falsely told investors that the Food and Drug Administration was “on the verge of approving DECN’s request for emergency use authorization” of the supposed blood test. [read post]
10 Dec 2023, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
8 Dec 2023, 5:03 am
The Palestinian Authority is working with the US on a plan to run Gaza after the war ends, Palestinian Prime Minister Mohammed Shtayyeh said yesterday. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 10:00 pm
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory. [read post]
7 Dec 2023, 9:05 pm
Food and Drug Administration (FDA), the U.S. [read post]
7 Dec 2023, 2:55 am
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. [read post]
6 Dec 2023, 9:36 pm
The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. [read post]
6 Dec 2023, 9:06 pm
As of Dec. 6 the Food and Drug Administration had received reports of 64 “adverse events” in children aged 6 and younger. [read post]
