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)
ADI - acceptable daily intakeADME - absorption, distribution, metabolism, and excretion
ADMIA (CBER) - Associate Director for Medical and International Affairs CBER
ADP - automated data processing
ADP (CBER) - Associate Director for Policy CBER
ADR - Adverse Drug Reaction
ADR - adverse drug report
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