505(b)(2) means A new drug application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. in FDA




Similar to 505(b)(2)

ACT - Applied Clinical Trials
ACTB (NCTR) - Analytical Chemical Techniques Branch NCTR
ACTH - AdrenoCorticoTropic Hormone
ACTIS - Aids Clinical Trials Information Service
ACUS - Administrative Conference of the United States
ACWA - Administrative Careers With America
AD - Action Due

View all in FDA