FAST TRACK USA REGULATORY APPROVAL FOR DRUGS TO TREAT EMERGING INFECTIOUS DISEASES

Pavithra Gm,Saba Maanvizhi

doi:10.22159/ajpcr.2021.v14i7.41761

Abstract

The Food and Drug Administration has established fast track approval to speed the designation of drugs that efficiently treat serious conditions, in particular those that provide improved advantages over available therapy. Fast track designation was initiated to curtail the time period in the new drug approval procedure and to promote the drug discovery and commercialization of drug products for critical and life-threatening illness and expedite the approval of drug products demonstrating advanced efficacy toward the prevailing one. Single Phase II study is reviewed before approving the drug within fast track designation. This review article highlights the consequences, criteria for fast track designation, fast track designation process, and the timeline for fast track approval.

Highlights

Numerous numbers of unmet medical needs along with limited no of drugs available for treatment of life threatening and rapidly spreading diseases like AIDS, HIV, tuberculosis, cancer, viral infections [1]
Whenever the drug product is authorized with the fast track designation process, this empowers investigators to operate together with the Food and Drug Administration (FDA) to carry out the trial and to submit the related data [9]
Advantages related to fast track designation can occur all over the drug development process, starting from the early Investigational New Drug (IND) submission to review of a marketing application, requests must usually arise within the sponsor Pre-New Drug Application (NDA) meet with the FDA Agency, the advantages of fast track approval will no more be appropriate after that time

Summary

Introduction

Numerous numbers of unmet medical needs along with limited no of drugs available for treatment of life threatening and rapidly spreading diseases like AIDS, HIV, tuberculosis, cancer, viral infections [1]. The FDA usually fast tracks drugs intended to treat life-threatening, rapidly spreading diseases and have fewer or no other treatments. A sponsor can request fast track designation together with the Investigational New Drug (IND) application [8].

Results

Conclusion