The qualification process comprises FDA review of specific documents submitted to the AMQP in three successive stages (i.e., Stage 1 – Letter of Intent, Stage 2 – Qualification Plan, and Stage 3 – Full Qualification Package).
Outlines for the content of the Letter of Intent and Qualification Plan are provided in the links in the table below. The contents of the Full Qualification Package will be determined based on discussions between the requestor and the AMQP. Study reports submitted as part of the Full Qualification Package should be final study reports and include the study protocol and amendments, line listings for each data point for each animal, tabular summaries, and full data analyses.
|Stage 1||Letter of Intent|
|Stage 2||Qualification Plan|
|Stage 3||Full Qualification Package|