CDISC-Gloss – Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL]
CDISC-Gloss – Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL]