FDA's Expedited Programs Explained

To encourage the creation of therapies, including drugs and biologics, that address unmet medical needs for serious conditions, the FDA has established several programs designed to expedite drug development and review processes. These four key programs are Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review.

Each of these programs offers distinct benefits and pathways to streamline the journey from development to market approval. Fast Track designation facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need. Breakthrough Therapy designation is designed for drugs that show preliminary clinical evidence of substantial improvement over existing therapies for serious conditions. Accelerated Approval allows for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate or intermediate clinical endpoint. Lastly, Priority Review shortens the review period for drugs that provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

Over the years, we have gained valuable insights into navigating these programs effectively. Guiding clients through the FDA’s expedited pathways and selecting the appropriate program can yield significant advantages. By thoroughly understanding the unique aspects of each expedited program, we can tailor a regulatory strategy that best aligns with the product’s characteristics and the specific needs of the medical community. This strategic approach not only facilitates a smoother development process but also enhances the likelihood of successful and timely approval, ultimately ensuring that critical therapies reach patients in need more efficiently.