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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]
6 Dec 2023, 9:05 pm
Food and Drug Administration and USDA’s Food Safety and Inspection Service (FSIS) has not brought transparency to the novel food. [read post]
6 Dec 2023, 1:49 pm
“If you are not sure if your cantaloupe is part of the recall, do not eat or use it and throw it away,” the company stated in its recall notice posted by the Food and Drug Administration. [read post]
5 Dec 2023, 9:01 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
5 Dec 2023, 1:49 pm
Food and Drug Administration (FDA) recently published a final rule amending “its regulations concerning direct-to-consumer (DTC) advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use. [read post]
4 Dec 2023, 9:36 am
Food and Drug Administration is considering requiring companies to conduct new animal tests for several sunscreen ingredients that have been in use for decades. [read post]
3 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]
