Regulatory

Fast Track

An FDA designation that facilitates development of drugs for serious conditions with unmet need.

Definition

Fast Track allows more frequent FDA interaction and may permit rolling submission of NDA sections. It is less intensive than Breakthrough Therapy designation.

Related terms

Breakthrough TherapyAn FDA designation that expedites development of drugs with preliminary evidence of substantial improvement over existing therapy.
IND ApplicationInvestigational New Drug application — FDA clearance required before human trials begin.

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