The FDA has several programs aimed at streamlining and accelerating the development and review of new drugs for the treatment of serious or life-threatening conditions, particularly where there is an unmet medical need.
These expedited programs ensure that treatments for such conditions are available as soon as possible, provided that the benefits of the therapy outweigh its risks, taking into account the severity of the condition and availability of other treatment options.
The programs include:
breakthrough therapy designation,
fast track designation,
accelerated approval, and
priority review
Fast Track Designation
Fast track designation is a program designed to accelerate the development and review of drugs that address serious medical conditions with an unmet need.
The designation may be granted based on preclinical data. Sponsors of drugs that receive fast track designation can expect more frequent interactions with the FDA during the drug development process.
Additionally, drugs that have received fast track designation can benefit from rolling review, allowing for the submission of completed sections of the New Drug Application (NDA) on a rolling basis rather than waiting for the entire application to be completed before submission.
Accelerated Approval
Accelerated approval program expedites the development and approval of drugs for serious or life-threatening conditions
Allows approval of drugs that show an effect on surrogate or clinical endpoints that can predict clinical benefit
Useful when disease course is lengthy and takes time to measure clinical benefit
Post-marketing trials may be required to confirm clinical benefit, and approval may be withdrawn if trials fail to verify predicted benefit
Priority Review
The Program applies to new molecular entity NDAs and original BLAs submitted from Oct 1, 2012, through Sep 30, 2017, including resubmissions following Refuse-to-File actions
For applications filed under the Program, the PDUFA review clock begins after the 60-day filing review period that starts from FDA receipt of the original submission
Any drug, including those with other designations like fast track or breakthrough therapy, can be granted priority review if relevant criteria are met
Differences between the criteria for breakthrough therapy designation and fast track designation?
Breakthrough therapy and fast track designation programs aim to accelerate drug development and review for serious or life-threatening conditions.
A breakthrough therapy designation requires preliminary clinical evidence that the drug can substantially improve a significant clinical endpoint over available therapies, while a fast track designation requires nonclinical or clinical data demonstrating the potential to address unmet medical needs for the serious condition.
