FDA'S NEW DRUG REVIEW PROCESS: AN OVERVIEW FROM OFFICIAL WEBSITE
Journal Title: Journal of Drug Discovery and Therapeutics - Year 2013, Vol 1, Issue 4
Abstract
Drugs are the vital and inevitable part of modern day treatment strategies. Drugs are always directly related with lives of human beings. There should be very strict approval process before getting permission for their marketing and ultimate licence for use of humans. FDA (U.S. Food and Drug Administration) is an agency which plays a vital role in the approval of millions of drug for market distribution and selling purposes. FDA’s Centre for Drug Evaluation and Research (CDER) is involved in the process of innovation and development of new drugs. Any new drug which is being invented always needs to go through the FDA’s guidelines mentioned in this review. All the data mentioned in this review has been taken from the official website of FDA just for the simplification of the original procedure mentioned on the website.
Authors and Affiliations
Dr. Satish Bahekar*| Demonstrator, Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Sewagram Wardha, Maharashtra 442102, India, Dr. Ranjana Kale| Professor, Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Sewagram Wardha, Maharashtra 442102, India
Keywords
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