Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, out-of-place medical claims.

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new information from the trial, the framework allows researchers to incorporate preexisting data at the outset, including details about drug performance gathered from earlier trials, or predictions based on similar drugs.

FDA allows “no artificial colors” claims for natural dyes, but undefined “petroleum-based” categories leave manufacturers seeking clarity.

The agency will no longer crack down on manufacturers that use natural dyes in foods labeled ‘No artificial colors.’ Here’s what experts want you to know.

FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to the commenter’s.

The Food and Drug Administration (FDA) announced Thursday it will not enforce federal regulations regarding “false or misleading” material on food labeling in regard to artificial food dyes, giving