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FDA protocol deviation guidance could go furtherThe US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
The proposals would see alcohol labeling come closer to that for non-alcoholic beverages: with serving sizes, calorie counts, ...
Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...
Dr. Dorothy Fink, the acting secretary for the Department of Health and Human Services under President Donald Trump, has ...
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
Liberty-based Vitti Labs, a human tissue bank, is suing the Food and Drug Administration over how the agency is regulating a ...
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