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- FDA gene and cell therapy review office loses acting director Vijay KumarVijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
- FDA reviewers recommend against adding seven peptides to bulk drug list for compoundingFDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…