Exploring the Five FDA Accelerated Programs

The FDA has several accelerated programs designed to expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions. These programs aim to facilitate earlier access to promising therapies for patients in need. Here are some of the key accelerated programs offered by the FDA:

1.     Fast Track Designation: The Fast Track program is designed to expedite the development and review of drugs that address unmet medical needs for serious or life-threatening conditions. It allows for more frequent interactions with the FDA, priority review of the marketing application, and the possibility of accelerated approval based on surrogate endpoints or intermediate clinical endpoints.

2.     Breakthrough Therapy Designation: The Breakthrough Therapy designation is intended for drugs that show substantial improvement over existing therapies for serious or life-threatening conditions. It provides all the benefits of Fast Track designation, as well as additional support and guidance from the FDA to facilitate the development and expedite the review of the therapy.

3.     Accelerated Approval: Accelerated Approval allows for earlier approval of drugs that demonstrate a meaningful advantage over existing treatments for serious conditions. This pathway is based on surrogate endpoints or intermediate clinical endpoints that are reasonably likely to predict clinical benefit, rather than definitive evidence of improved clinical outcomes.

4.     Priority Review: Priority Review designation is granted to drugs that offer significant improvements in the safety or effectiveness of treatment, diagnosis, or prevention of serious conditions compared to standard therapies. It shortens the FDA review time from the standard 10 months to 6 months, expediting the approval process.

5.     Priority Review Voucher Program: The Priority Review Voucher (PRV) program incentivizes the development of drugs for neglected tropical diseases and rare pediatric diseases. Under this program, sponsors who receive FDA approval for a qualifying drug can receive a voucher that can be used to obtain priority review for another drug of their choice or sold to another company.

These accelerated programs are intended to encourage the development of innovative therapies for serious conditions and to expedite their availability to patients in need. They provide various incentives and expedited pathways to facilitate the development, review, and approval of promising drugs and biologics.