Abstract

THE APPROVAL OF DRUG PROCESS: A REVIEW

Gujral G.*, Kapoor D. and Jaimini M.

ABSTRACT

It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.A new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act.‖ The approval of NEW drug requires pre-clinical, Clinical studies (Phase I, II & III), Chemistry, Manufacturing and Control etc. data. Getting approval and successful launching of product into market is very difficult and success rate is very less. Pharmaceutical companies are investing reasonably good amount of money and time to get one drug approval and successful launch into the market.

Keywords: Investigational new drug (IND) Emergency use investigational new drug (EIND) New drug application (NDA) Abbreviated new drug application (ANDA) Food and drug administration (FDA) Reference listed drug (RLD)