Speed your time to market with expedited programs from the FDA

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.

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