Galderma believes clinical trials are the most appropriate way for patients to access investigational medical products developed by Galderma. In these trials, the safety and efficacy of the investigational medical products are rigorously assessed by Galderma and the relevant regulatory agencies in order to understand the investigational medical products benefits, risks, and appropriate use, including whether or not they should be approved as a therapy for their intended use. Obtaining regulatory approval allows Galderma to bring safe and effective investigational medical products to the greatest number of patients who may benefit from treatment.
Galderma recognizes terminology for describing Early Access varies. Terminology used can include: Pre-Approval Access (PAA), Managed Access Programs (MAP), Expanded Access Programs (EAP), Compassionate Use, etc. Galderma defines this access as “Early Access”. Currently, Galderma does not offer Early Access for use of investigational medicinal products.
Galderma may revise this position as its clinical development programs progress.