610.12 CBER PROPOSED STERILITY TESTS

PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED   Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf The authority citation for 21 CFR part 610 continues to read…