ISSN: 2249–9504
CAS CODEN: IJPCDX

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

Abstract

Author(s): P. Nagaraju, K. Gowthami*, T. Lakshmi, MV. Nagabhushanam, D. Nagarjuna Reddy

UShavebeenconsideredprimary pharmaceuticalmarketintheworldsince longback.USpharmaceuticalmarketshares30to35% ofglobalpharmaceutical marketdespitelowgrowthrate inlasttwoyears.TremendousgrowthofUSpharma sectorisbasedonthreeprevailingfactorslikepresenceofbigpharma playersinthe county,governmentwillingnesstoprovide healthcarefacility andthirdlargest populationwith315million.Pharmacompanieshave threeways,NDA (NewDrug Application),ANDA(AbbreviatedNew DrugApplication)andOTC(Over The Counter)monograph,tomarkettheirdrugproductsinUS.NDA505(b) (2)isoneof thetypesof NDA. Section505(b)(2)wasintroducedinFD&CactthroughHatchWaxmanAct1984andbecomingpopularday by dayduetoitsimportance.505(b)(2) applicationhaschangedtheconceptof new drugdefinition.505(b)(2) isstillunder its revolvingstageandFDAistakingallstepstokeepthings inlinewithout compromising to safety &efficacy which are utmost important from FDA perspective.FDAhasstartedemphasizingonaccess,affordabilityandqualityofdrug. ShortageofdrugisbeingaprobleminUSand 505(b)(2)applicationhascomein support ofFDA to solveit because it takes less timeto get through regulatory approvalprocess.505(b)(2)applicationmotivatesinnovationandatthesametime drugproduct pricedonotsurge highlike 505(b)(1)applicationduetoitslow requirementoffinanceindrugdevelopmentphase.Keepingaboveviewpointin mind,thisstudy encompassesdevelopmentof505(b)(2)applicationinthehistory of FDA,eligibility for505(b)(2)application,submissionrequirementsanddetailed CDER (Centerof DrugEvaluation and Research)reviewprocess ofNDA.

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