Clinical Labeling - Overview
During drug development, companies may utilize a variety of clinical labeling-related tools that employ target labeling to facilitate drug development, while aligning with the desired marketing and labeling objectives in the development program design/study design, and drafting the Clinical Overview (CO).
It is important for companies to employ a modular approach while collecting safety and efficacy information across various types of clinical labels. This would effectively help investigators and sponsors by presenting and updating a focused and dedicated Development Core Safety Information (DCSI) section that can conveniently be placed under the different clinical categories. Furthermore, the DCSI develops into the Company Core Safety Information (CCSI) that is included in the first Company Core Data Sheet (CCDS) and is utilized for the product's market entry. Drafting a thorough CO comprising the scope and critical issues in the drug’s clinical developmental program is also required to support the documentation for the assessors.
Clinical Labeling - Expertise
- Creation and review of Investigational Brochure (IB)
- Development of Target Labeling (TL)/Target Profile (TP)
- Development and review of Developmental Core Data Sheets (DCDS) & DCS
- Development and review of FDA Target Product Profile (TPP), EU-draft SmPC (dSmPC)
