PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

摘要

PDA's PAC iAM (Post-approval Change: Innovation for Availability of Medieines) program has been established with the objective to identify, assess, and address current barriers to implementation of post-approval changes (PACs) that are intended to ensure continued operations, maintain a state fof control, and drive innovation and continual improvement.