Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.
The Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License" issued recently in the Federal Register. The purpose of the public workshop is to provide interested persons an opportunity to more clearly understand the proposed rule and its effect on industry and the public.
D001688:Biological Products; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004493:Education; D006801:Humans; D008004:Licensure / Q000331:legislation & jurisprudence*; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products