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)
ADAA - Animal Drug Availability Act of 1996ADaM - Analysis Dataset Model
ADAMHA - Alcohol, Drug Abuse, and Mental Health Administration now SAMHSA
ADCOM - advisory committee
ADE - Adverse Drug Event
ADE/ADER - Adverse Drug Experience/Adverse Drug Experience Report
ADEC - Australian Drug Evaluation Committee
View all in FDA