Zdrowie i gospodarka · 25.02.2003
Draft Guidance for Industry on Comparability Protocols-Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Comparability Protocols--Chemistry, Manufacturing, and Controls Information." This draft document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information.