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24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [read post]
24 Oct 2023, 3:49 pm by Bill Marler
Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Salmonella Thompson infections. [read post]
24 Oct 2023, 3:08 pm by News Desk
Food & Drug Administration notified it that the recalled products were part of the agency’s traceback investigation into an ongoing Salmonella Thompson outbreak. [read post]
24 Oct 2023, 10:49 am by Laura Ray
Food and Drug Administration (FDA) recently created a Digital Health Advisory Committee to provide relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks, and clinical outcomes associated with use of Digital Health Technologies (DHTs),” as well as identify “risks, barriers, or unintended consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. [read post]
24 Oct 2023, 8:47 am by jeffreynewmanadmin
Schena also falsely announced that Arrayit had developed a COVID-19 test, even though the US Food and Drug Administration (FDA) had informed him that the Arrayit’s test was not accurate enough to receive an Emergency Use Authorization (EUA), which he concealed from investors. [read post]
22 Oct 2023, 9:05 pm by Peter Grossi
Food and Drug Administration’s 2016 and 2021 decisions modifying the agency’s regulatory requirements for the use of the principal abortion medication, mifepristone. [read post]
19 Oct 2023, 9:05 pm by Gianna Hill
The Food and Drug Administration (FDA) proposed a ban on hair-straightening products that contain or emit formaldehyde, a highly toxic gas. [read post]
19 Oct 2023, 3:46 pm by Coral Beach
They expressed a general lack of confidence in the food side of the massive Food and Drug Administration. [read post]
FDA also argues that LDTs “are often used interchangeably by healthcare providers and patients with tests made by other manufacturers,” and that “test systems are often ‘launched as LDTs’ with no assurance that they meet requirements under the [Federal Food, Drug, and Cosmetic Act (FD&C)] Act and its implementing regulations. [read post]
17 Oct 2023, 9:01 pm by News Desk
Food and Drug Administration (FDA) and Europol led the operation targeting counterfeit olive oil. [read post]
13 Oct 2023, 7:24 am by Clay Hodges
Food and Drug Administration (FDA) issued a Safety Communication notifying the public that Philips had recalled certain BiPAP, CPAP and ventilator machines. [read post]