Revisions to the general safety requirements for biological products; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by adding cellular therapy products to the list of products exempted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the GST may not be relevant or necessary for many types of biological products, including cellular therapy products, currently in various stages of development.