A REGULATORY PERSPECTIVE OF 505 (b) (2) NEW DRUG APPLICATION.

US have been considered primary pharmaceutical market in the world since long back. US pharmaceutical market shares 30 to 35% of global pharmaceutical market despite low growth rate in last two years. Tremendous growth of US pharma sector is based on three prevailing factors like presence of big pharma players in the county, government willingness to provide healthcare facility and third largest population with 315 million. Pharma companies have three ways, NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and OTC (Over The Counter) monograph, to market their drug products in US.NDA 505 (b) (2) is one of the types of NDA. Section 505 (b) (2) was introduced in FD&C act through Hatch-Waxman Act 1984 and becoming popular day by day due to its importance. 505 (b) (2) application has changed the concept of new drug definition. 505 (b) (2) is still under its revolving stage and FDA is taking all steps to keep things in line without compromising to safety & efficacy which are utmost important from FDA perspective. FDA has started emphasizing on access, affordability and quality of drug. Shortage of drug is being a problem in US and 505 (b) (2) application has come in support of FDA to solve it because it takes less time to get through regulatory approval process. 505 (b) (2) application motivates innovation and at the same time drug product price do not surge highlike 505 (b) (1) application dueto its low requirement of finance in drug development phase. Keeping above viewpoint in mind, this study encompasses development of 505 (b) (2) application in the history of FDA, eligibility for 505 (b) (2) application, submission requirements and detailed CDER (Center of Drug Evaluation and Research) review process of NDA. [ABSTRACT FROM AUTHOR]