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How Regulatory CMC Experts Navigate Expedited Accelerated Approval Timelines

Picture this: a pharmaceutical company just received an accelerated approval designation by the FDA for their lead candidate, though exciting, the expedited timelines and deliverables felt like their team was reaching for the stars. Meeting expedited timelines and scenario planning became the main focus for this team, and they began evaluating the demands, risks, and benefits of the designation, and asked themselves ‘can we really pull this off?’

Regulatory Chemistry, Manufacturing, and Controls (CMC) experts on the team reiterated that the manufacturing and characterization requirements to ensure product safety and quality are not relaxed, but the timing is adjusted. Even understanding this compressed timeline before they applied for accelerated approval, the company is still left facing manufacturing deliverable concerns and in retrospect, wished they had established more proactive planning before submitting their application.

Below you’ll find ideas on how to bring a Regulatory CMC ‘checks and balances’ perspective early on around navigating expedited timelines for accelerated approval designations before the application is submitted.

Accelerated Approvals: Saves Time, but Requirements Remain

An Accelerated Approval allows product developers to save significant time because the FDA may consider the product reasonably likely to predict a real clinical benefit based on a surrogate endpoint. Successful utilization of an expedited program can reduce development time by more than two years when compared to traditional drug development timelines, sometimes reaching 15+ years. Such a designation, however, demands a diligent development plan with advanced scenario planning before the accelerated approval application is submitted. In addition to robust timelines, accelerated approvals also allow more opportunities for sponsors to engage with the FDA and become a partner in advancing an unmet medical need.

But this time savings can introduce major challenges for regulatory CMC aspects of product development since expedited development does not lessen regulatory safety requirements.

Navigating the Risks of an Accelerated Approval Designation

We cannot overemphasize the value of upfront planning. Product developers should discuss the possibility of accelerated approval with the review division of the FDA during development, including the use of the planned endpoint that is reasonably likely to predict the intended benefit of the drug as a basis for approval. Having these upfront planning discussions will help ease the burden of ‘can we pull this off’ after receiving the designation and move the team into a more proactive mindset.

Additionally, the developers should also discuss their confirmatory trials with the FDA and there should be an agreement with the FDA on the design and conduct to support the confirmation of the clinical benefit. Typically, the confirmatory trial should already be underway at the time of the application for accelerated approval.

Balancing development activities once an accelerated approval has been granted can be a tricky game, often resulting in a lot of risk management. As companies identify with the above scenario, it’s important to pause and create a risk assessment and strategy well in advance to meet the expedited timeline demands.

Risks and opportunities, but certainly not limited to:

Every product development path is unique and has its challenges, and when introducing potential new challenges such as expedited timelines, it’s absolutely essential to understand risks and mitigation strategies upfront so that when the FDA grants an accelerated approval designation, you’ll be able to move forward with a strategic plan and make minor adjustments along the way.


To learn more about Halloran’s Regulatory CMC capabilities, please contact a member of our team to learn more about how we help companies like yours navigate accelerated development pathways.