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Archive for 2023

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

January 26, 2023

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for…

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward FDA
FDA Roundup: January 24, 2023

January 24, 2023

FDA Roundup: January 24, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA issued a final…

FDA Roundup: January 24, 2023 FDA
FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

January 24, 2023

FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company. The…

FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard FDA
FDA Announces Action Levels for Lead in Categories of Processed Baby Foods

January 24, 2023

FDA Announces Action Levels for Lead in Categories of Processed Baby Foods

Today, the U.S. Food and Drug Administration is announcing draft guidance for industry on action levels for lead in processed foods that are intended for…

FDA Announces Action Levels for Lead in Categories of Processed Baby Foods FDA
FDA Roundup: January 13, 2023

January 13, 2023

FDA Roundup: January 13, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA released a fact sheet…

FDA Roundup: January 13, 2023 FDA
Providing Review-Ready Results in SDTM

January 6, 2023

Providing Review-Ready Results in SDTM

Findings results as originally collected may not be review ready for a variety of reasons, so SDTM has a variable, –ORRES, for the result as…

Providing Review-Ready Results in SDTM CDISC
FDA Roundup: January 06, 2023

January 6, 2023

FDA Roundup: January 06, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA posted an update that…

FDA Roundup: January 06, 2023 FDA
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

January 6, 2023

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second…

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment FDA

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