Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction.
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000592:standards*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D008004:Licensure / Q000331:legislation & jurisprudence*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration