CDISC-Gloss – An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR
314.3; Guidance to industry and FDA staff (10/08/2003)]
CDISC-Gloss – An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR
314.3; Guidance to industry and FDA staff (10/08/2003)]