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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]
3 Dec 2023, 9:00 pm
Food and Drug Administration. [read post]
1 Dec 2023, 2:34 pm
The outbreak stretches across 34 states, according to the Food and Drug Administration. [read post]
30 Nov 2023, 9:05 pm
The outbreak stretches across 34 states, according to the Food and Drug Administration. [read post]
30 Nov 2023, 4:25 pm
Food and Drug Administration had already concluded that the cinnamon in certain applesauce products was the source of the lead. [read post]
29 Nov 2023, 8:41 am
Teva (No. 23-___): I expect Vanda to challenge the Federal Circuit’s decision on the obviousness of its patents covering methods of using a particular drug. [read post]
29 Nov 2023, 5:00 am
He has an extensive background in chemistry, food science, and viticulture. [read post]
28 Nov 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]
28 Nov 2023, 2:36 pm
Cantaloupes recalled by TruFresh were used as a raw material in Kwik Trip, Inc. fruit cup and tray products listed below, according to the company’s recall notice posted by the Food and Drug Administration. [read post]
27 Nov 2023, 9:50 am
Food and Drug Administration (FDA). [read post]
