Electronic Submission requirements for ANDAs: Are you ready?
CDER SBIA Webinar Series
Electronic Submission requirements for ANDAs:
Are you ready?
Jonathan Resnick
Project Management Officer Division of Data Management Services & Solutions Office of Business Informatics Center for Drug Evaluation and Research U.S. Food and Drug Administration
Julia Lee, Pharm.D.
Acting Deputy Director Division of Filing Review Office of Regulatory Operations Office of Generic Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration
November 21, 2016
Agenda
? eCTD Requirements and Timeline
? Where to find eCTD resources
? The ESG (Electronic Submission Gateway)
? CDER eCTD Processing
? Common eCTD Deficiencies
? How OGD (Office of Generic Drugs) will handle eCTD deficiencies
? Questions
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eCTD Requirements and Timeline
? May 5, 2017: NDA, BLA, ANDA and DMFs must be in eCTD format
? May 5, 2018: Commercial INDs must be in eCTD format ? Do not send Paper and/or non-eCTD submissions after
these deadlines!
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eCTD Requirements and Timeline
STUDY Data Standards Resources
? What's New
? Studies that start after December 17, 2016 must be in
standardized format for NDA, BLA and ANDA submissions ? Study Data Technical Conformance Guide
? Validation Codes
See Technical Rejection for Study Data. Currently posted on eCTD Website at
ectd
? When
CDER will start using the new validation criteria - TBD
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