The FDA offers five expedited programs for products that address unmet medical needs for serious or life-threatening conditions – and the goal of these programs is to ensure therapies are made available to seriously ill patients, as soon as possible. One of the most recent and high-profile products to receive “Fast Track” designation from the FDA was mRNA-1273, Moderna’s potential vaccine for COVID-19, which was granted the designation in May of 2020. As an increasing number of drugs in development focus on areas of unmet medical need, it’s important for developers to understand FDA expedited approval programs; the degree to which each one can compress development and marketing application review timelines; and the most current utilization rates for each. Armed with a better understanding of these programs, sponsors are in a better position to accelerate the development and regulatory review process and get therapies to patients, faster.
Cardinal Health Regulatory Sciences (CHRS) has more than four decades of experience supporting pharmaceutical and biotech companies in getting their products to market quickly – CHRS associates have supported approximately 30 original marketing applications utilizing one or more expedited program application. Our Expedited Pathways Center of Excellence features cross-functional experts in non-clinical, clinical, chemistry, manufacturing and controls and regulatory affairs – each of whom is committed to helping developers realize the full benefits of these expedited programs. Learn more about our tailored approaches to guide expedited programs at our Expedited Pathways Center of Excellence landing page