Inside Story for Review of an Abbreviated New drug Application

Gupta Rajkumar

《International Journal of Drug Regulatory Affairs》 2卷1期 (2014/03) Pp. 29-31

並列摘要

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.

並列關鍵字

ANDA ； FDA ； NDA ； eCTD ； DMF