Open AccessINSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION
Author(s) -
Rajkumar Gupta
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i1.122
Subject(s) - authorization , internet privacy , computer science , business , marketing authorization , computer security , drug , medicine , pharmacology , bioinformatics , biology
ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.