
(AGENPARL) – SILVER SPRING gio 23 marzo 2023 Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.
Fonte/Source: http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/methods-and-approaches-capturing-post-approval-safety-and-efficacy-data-cell-and-gene-therapy