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)

ABM - Application Briefing Meeting
ABRA - American Blood Resource Association
AC - Advisory Committee
ACB - Accreditation and Certification Branch
ACBSA - Advisory Committee on Blood Safety and Availability HHS
ACC - RCHSA Radiation Control for Health and Safety Act accession number ORA AofC code
ACCME - Accreditation Council for Continuing Medical Education

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