Some additional DD for those wanting to know more....
Over the years the FDA has implemented numerous measures to expedite selected treatments or drugs.
I have extracted the main four steps for easy reference, but have added the document link below. It contains more comments on the combination of the below steps etc...its be best I have seen till date on explaining this topic. (please note that it is from 2015, so there could be some small updates till then, but I am certain the main principle is still applicable)
Priority Review: The primary benefit of receiving Priority Review is a reduction of four-months in the projected review time by FDA. FDA aims to complete review of an NDA for a compound with a Priority Review designation within six months; the goal for a compound with a Standard Review designation is to complete review within ten months
Under FDA's Guidance and the updated CDER MAPP 6020.3, to receive Priority Review, the new product must treat a serious or life-threatening condition and “provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies,” if approved
Accelerated Approval:
The Accelerated Approval mechanism benefits a sponsor or manufacturer by facilitating shorter clinical trials. Rather than waiting for data on a clinical endpoint, Accelerated Approval permits a sponsor or manufacturer to utilize an event that may occur earlier in time
For a new compound to qualify for Accelerated Approval141 following the enactment of FDASIA, it must address a serious or life-threatening condition and demonstrate an effect on a surrogate endpoint or an intermediate clinical endpoint other than a direct measure of mortality or survival.142 The surrogate endpoint or intermediate clinical endpoint must be “reasonably likely to predict” the clinical benefit or an effect on irreversible morbidity or mortality
Fast Track Approval:
An investigational new drug product is eligible for Fast Track designation if “it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition
Fast Track designation provides several benefits to a sponsor. Rolling review of a Fast Track product's NDA may be possible if FDA finds that a “fast track product may be effective” based on a “preliminary evaluation of clinical data submitted by the sponsor,” and other administrative criteria167 are met.168 This enables FDA to review “portions of[] an application for the approval of the product before the sponsor submits a complete application,” potentially expediting the review process. In addition, Fast Track designation permits frequent interaction between a sponsor and the FDA review team. Meetings are possible prior to submitting an IND application, at the end of Phases 1 and 2 and at other times, as appropriate.
Breakthrough Designation:
Breakthrough Therapy designation—applies to a new drug product if it “is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints.
The designation entitles a sponsor to “appropriate actions [by FDA] to expedite the development and review of an application for approval of a breakthrough therapy.” FDASIA lists several examples of potential actions that FDA may take. These focus on creating a collaborative and close process between FDA and the sponsor through the commitment of timely communication and meetings, experienced and senior FDA personnel, an FDA employee responsible for coordinating the review within FDA, and efforts by FDA to make the trials as efficient and small as practicable.In its Final Guidance, FDA has reiterated these benefits and added that a Breakthrough Therapy product may obtain rolling review and “could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.”185
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