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FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
JD Supra3d
Navigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
JD Supra1d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
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Kennedy Commits to Diverse Clinical Trial Regulations Amid FDA Scrutiny
Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...
Beverage9d
New US alcohol labeling rules proposed
The proposals would see alcohol labeling come closer to that for non-alcoholic beverages: with serving sizes, calorie counts, ...
JD Supra2d
FDA Releases Proposed Front-of-Package Nutrition Labeling Rule
On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...
JD Supra10d
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Trump Administration Orders a Temporary Freeze on Food and Health Agency Communications
Dr. Dorothy Fink, the acting secretary for the Department of Health and Human Services under President Donald Trump, has ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
JD Supra10d
FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
Liberty human tissue bank sues FDA over regulation of umbilical cord product
Liberty-based Vitti Labs, a human tissue bank, is suing the Food and Drug Administration over how the agency is regulating a ...