How Regulatory CMC Experts Navigate Expedited Accelerated Approval Timelines

By Tiffany Leemkuil

Imagine a pharmaceutical company that has just received an accelerated approval designation from the FDA for their lead candidate. While this is an exciting milestone, the expedited timelines and deliverables felt like a stretch for the team. They quickly shifted their focus to meeting these new timelines and planning for various scenarios. Evaluating the demands, risks, and benefits of the designation, they wondered, "Can we really pull this off?"

Regulatory Chemistry, Manufacturing, and Controls (CMC) experts on the team emphasized that while the timing may be adjusted, the manufacturing and characterization requirements to ensure product safety and quality remain stringent. Despite understanding the compressed timeline before applying for accelerated approval, the company still faces concerns about meeting manufacturing deliverables. In hindsight, they wished they had implemented more proactive planning before submitting their application.

Below, you will find suggestions on incorporating a Regulatory CMC 'checks and balances' perspective early in the process to navigate expedited timelines for accelerated approval designations before submitting the application.