eCTD Issues for ANDA Submissions

• By: Rajesh Yelugoila
• Date: February 03, 2016
• Source: http://www.regulatoryone.com/2016/01/ectd-issues-for-anda-submissions.html

Post the implementation of GDUFA, in the current year 4 cohort of FY 2016, there has been a very significant positive change with respect to ANDA review timelines. The initial screening deficiencies/ information requests or acceptance letters are generally being issued within 1 month of filing ANDAs. The most important screening deficiency/information request issued by USFDA is related to eCTD aspects, which in general is given least importance. RA professionals generally ensure to meet the requirements of ANDA Filing Checklist, which doesn’t summarize the eCTD requirements in detail, but gives a link to USFDA website where we get all the guidelines and eCTD requirements details.