FDA Final Guidance: Certain Postapproval Requirements and Resources for ANDAs

FDA CDER issued the final guidance 'Certain Postapproval Requirements and Resources for ANDAs' on 4 June 2026. This guidance consolidates and clarifies obligations that ANDA holders must meet after generic drug approval, including: (1) Labelling maintenance: ANDA holders must maintain labelling parity with the Reference Listed Drug (RLD) and submit CBE-0 or CBE-30 supplements for labelling updates as required; (2) Annual product review and change reporting: annual reports must include all manufacturing, control, and labelling changes made in the preceding year; (3) CMC postapproval changes: obligations under 21 CFR 314.70 for ANDA holders regarding major, moderate, and minor changes to manufacturing, specifications, and controls; (4) Promotional materials: compliance with 21 CFR 202 for generic prescription drug advertising; (5) REMS postapproval obligations where applicable; (6) Resources and FDA contacts for ANDA postapproval questions. This guidance is directly relevant to the estimated 2,000+ ANDA holders in the US generics market. Non-compliance with postapproval obligations can result in Warning Letters, enforcement actions, and product recalls. Generic drug manufacturers should conduct an immediate compliance gap analysis against the finalised guidance.