INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION
Abstract
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.
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References
http://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application
2. FDA. Abbreviated New Drug Application (ANDA) Forms and Submission Requirements [Internet]. US: U.S. Food and Drug Administration; [date unknown] [updated 2014 March 28; cited 2013 Oct 22]. Available from: http://www.fda.gov/
3. FDA. Question-Based Review for CMC Evaluations of ANDAs [Internet].US: U.S. Food and Drug Administration; [date unknown] [updated 2012 Jan 13; cited 2013 Oct 17]. Available from: http://www.fda.gov/
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