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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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as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, 3:49 pm
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
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, 2:49 pm
There are 73 confirmed patients from 22 states, according to the Food and Drug Administration and the Centers for Disease Control and Prevention. [read post]
24 Oct 2023, 10:49 am
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
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]
23 Oct 2023, 2:38 pm
The potential choking hazard was confirmed after discussion with a representative from the Food and Drug Administration. [read post]
23 Oct 2023, 5:26 am
Food and Drug Administration (FDA) released guidance on cybersecurity in medical devices for quality system considerations and on premarket submissions. [read post]
22 Oct 2023, 9:05 pm
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]
22 Oct 2023, 9:01 pm
Kari-Fresh LLC2501 Lott Road, Donna, TX On June 26 through June 28, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Kari-Fresh LLC located at 2501 Lott Rd., Donna, TX 78537. [read post]
20 Oct 2023, 10:02 pm
This recall is being issued with the knowledge of the Food and Drug Administration. [read post]
20 Oct 2023, 4:33 pm
Food and Drug Administration issued the warning after the Canadian Food Inspection Agency found Salmonella and E. coli contamination in samples of oysters harvested from Future Seafoods Inc. harvest area. [read post]
20 Oct 2023, 3:54 pm
Food and Drug Administration issued the warning after the Canadian Food Inspection Agency found Salmonella and E. coli contamination in samples of oysters harvested from Future Seafoods Inc. harvest area. [read post]
19 Oct 2023, 9:05 pm
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
They expressed a general lack of confidence in the food side of the massive Food and Drug Administration. [read post]
18 Oct 2023, 9:00 am
In today’s video, we talk about when your product is likely to cross the line and be regulated by the federal Food & Drug Administration (“FDA”) as a cosmetic and not a prescription or Over the Counter (“OTC”) drug. [read post]
18 Oct 2023, 5:57 am
Food and Drug Administration (FDA). [read post]
18 Oct 2023, 5:57 am
Food and Drug Administration (FDA). [read post]
18 Oct 2023, 5:57 am
Food and Drug Administration (FDA). [read post]
18 Oct 2023, 3:15 am
For example, in the United States, the Consumer Financial Protection Bureau, Department of Justice, Equal Employment Opportunity Commission, Food and Drug Administration, Federal Trade Commission and the Securities and Exchange Commission each has issued guidance or otherwise indicated through enforcement activity that they view AI as within their respective purview of current regulatory and enforcement authority. [read post]
