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RegisterADaM and SDTM files submission question for Generic products [Regulatives / Guidelines]
Let me ask the question in a Different way:
Before CDISC became mandatory, we were submitting 2 SAS.xpt data files (PKParam.xpt and Concent.xpt with define file as PDF), now our question is do we continue to submit PKParam.xpt and Concent.xpt in addition to ADaM and SDTM files or we don’t need to submit these two files and ADaM and SDTM files are just sufficient? – This question is in regards to ANDA submissions targeted for OGD review.
Your clarification will greatly help us and thank you in advance for your guidance.
AchievWin
USA
Before CDISC became mandatory, we were submitting 2 SAS.xpt data files (PKParam.xpt and Concent.xpt with define file as PDF), now our question is do we continue to submit PKParam.xpt and Concent.xpt in addition to ADaM and SDTM files or we don’t need to submit these two files and ADaM and SDTM files are just sufficient? – This question is in regards to ANDA submissions targeted for OGD review.
Your clarification will greatly help us and thank you in advance for your guidance.
AchievWin
USA
Complete thread:
- PC PP domains for CDISC submission Abc123 2017-05-29 12:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
- ADaM and SDTM files submission question for Generic productsAchievwin 2017-07-23 16:01
- ADaM and SDTM files submission question for Generic products Shuanghe 2017-07-24 18:53
- ADaM and SDTM files submission question for Generic productsAchievwin 2017-07-23 16:01
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
Ing. Helmut Schütz