ABSTRACT
A marketing application represents the culmination of the work conducted under an asset’s Clinical Development Plan (CDP) and CMC Development Plan. It contains the evidence that a regulatory authority needs to deem the new chemical entity as being safe and effective to treat a disease as indicated on the product label. Development of a market application submission (MAS) can be considered a project unto itself within the development project. It often requires tightly controlled plans and schedules to keep a large group of authors organized and oriented. This chapter describes some best practices for the development of a MAS, including the team structure, roles, and responsibilities definitions; a description of the content creation process; and the use of a lexicon and message maps. The chapter also describes the activities to be carried out around drafting a label, writing clinical study reports (CSRs) and narratives, and collection of administrative documents to satisfy Module 1.13.1 Introduction
