AUPAM · Regulatory response planner
Turn each authority question into an action, an evidence reference and an accountable review.
Draft text stays in this page. Download a backup to resume later; refreshing or switching language may discard edits. Use document references rather than patient details or confidential source data.
AUPAM working aid. Check the authority, procedure and current letter first. This tool checks missing planning fields; it does not judge scientific adequacy or submit a response.
Includes incomplete items. A field check does not confirm acceptance, evidence quality or a valid regulatory deadline.
Start with one authority question. No response has been prepared yet.
The workflow and case are AUPAM editorial aids. The two examples below are specific to FDA ANDA complete response letters; they do not set deadlines or procedures for Arab authorities, EMA, NDAs or BLAs.
FDA · Final guidance · Revision 1 · October 2022 · Sections II, IV and VIII
This pathway distinguishes clarification of an identified deficiency from requests to assess new data or alternative approaches. Consult the source for eligibility and timing.
FDA · Final guidance · Revision 1 · December 2022 · Sections III.C–D
An extension request should explain the reason, work remaining, progress and time requested. The authority evaluates the request; do not assume approval.
Editorial source review: 19 September 2026. Final guidance contains nonbinding recommendations unless it cites applicable law.
