NEW DRUG DEVELOPMENT AND VARIOUS DRUG APPLICATIONS UNDER FDA

Kolla Chaitanya Prasad

doi:10.22270/ijist.v1i1.1

Kolla Chaitanya Prasad Softgel Healthcare Pvt Ltd, Pudupakkam, Chennai-603103, India

DOI: https://doi.org/10.22270/ijist.v1i1.1

Keywords: CDER, FDA, IND, NDA, ANDA, OTC, BLA, PDUFA, Orange Book, OGD, CFR, NME

Abstract

New drug is the one which is not previously available and intended to cure the unmet medical need. New drug development is very critical because there is no guarantee for the success of development. One of major stage in drug development is clinical phases, where phase 1 is conducted in healthy volunteers in small group, where phase 2 is conducted in small group of patient population, phase 3 is on large group of patient population, and at last after new marketing phase 4 starts, this is to identify unknown uses and adverse effect which are not found in previous phases. FDA is considered to be the world’s most stringent drug regulatory body. New drug is evaluated by various professionals in their departments from CDER.

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