Status Report Review Form MAPP Out

CDER has issued a Manual of Policies and Procedures, Procedures for Completing and Processing the Form “Annual Status Report Review Form: PMR and PMC Summary,” describing procedures used by Office of New Drugs (OND) staff to (1) verify an applicant’s reported status and explanation of status for postmarketing requirements (PMRs) and postmarketing commitments (PMCs), and (2) complete the form “Annual Status Report Review Form: PMR and PMC Summary.”

The MAPP does not apply to PMCs not subject to the reporting requirements of section 506B of the Federal Food, Drug, and Cosmetic Act, such as PMCs related to chemistry, manufacturing, and controls.

The policy is that OND staff, in consultation with other review staff as necessary, will review an applicant’s Annual Status Report within three months of receipt to determine whether OND agrees with the applicant’s reported status and explanation of status for each reportable PMR and PMC.