INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION

  • Rajkumar Gupta

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.

Keywords: ANDA, FDA, NDA, eCTD, DMF.

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References

1. Wikipedia, the free encyclopedia. Abbreviated New Drug Application [Internet].US: United States Department of Health and Human Services; 2013 [updated 2013 Aug 31; cited 2013 Oct 20]. Available from:
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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How to Cite
Gupta, R. “INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 1, Feb. 2018, pp. 29-31, doi:10.22270/ijdra.v2i1.122.