Eriko S. Yoshimaru

Dec 11, 2024 | jdsupra.com | Eriko S. Yoshimaru

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial intelligence-enabled device software function (AI-DSF).

Feb 17, 2024 | lexology.com | Stephanie Agu |Heidi Forster Gertner |Blake Wilson |Eriko S. Yoshimaru

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity Data in Clinical Trials,” which provides recommendations on the standardized collection of race and ethnicity data.