The Essential Post-Approval Compliance Checklist for NDA Holders

Receiving an NDA approval letter is a moment of triumph, but it immediately triggers a new set of obligations. Many sponsors, especially smaller ones, underestimate the rigor of post-marketing requirements (PMRs) and commitments (PMCs). Failure to meet these milestones can result in public "Failure to Respond" letters or even withdrawal of approval.

Primary compliance focus areas must include the Annual Report (due within 60 days of the approval anniversary), quarterly safety reports (PADERs or PSURs), and strict adherence to the drug advertising and promotion regulations (OPDP). CMC changes are another frequent pitfall; sponsors must correctly categorize changes as CBE-0, CBE-30, or Prior Approval Supplements (PAS) based on risk.

Mevoq provides a "Compliance Watch" service that manages this entire lifecycle. We recently helped a client remediate a backlog of overdue Annual Reports, successfully negotiating with the FDA to avoid a Warning Letter by demonstrating a corrected and robust quality system.