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)
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