Revisions to the general safety test requirements for biological products--FDA. Direct final rule: confirmation in part and withdrawal in part.
The Food and Drug Administration (FDA) is confirming in part and withdrawing in part the provisions in the direct final rule that published in the Federal Register of April 20, 1998, to revise the general safety test (GST) requirements for biological products. FDA is confirming the part of the rule about which no significant adverse comment was received and withdrawing the part about which significant adverse comment was received.
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000592:standards*; D006801:Humans; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration