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RegisterNew FDA CDISC requirements for ANDAs [Regulatives / Guidelines]
Hi all,
Starting in December all BE studies will require data to be submitted in CDISC format. I was wondering if anyone knew what is specifically required? Are SDTM, i.e. PC and PP datasets sufficient or do we need to provide the AdAM datasests ADPC and ADPP, as well?
Thank you.
Starting in December all BE studies will require data to be submitted in CDISC format. I was wondering if anyone knew what is specifically required? Are SDTM, i.e. PC and PP datasets sufficient or do we need to provide the AdAM datasests ADPC and ADPP, as well?
Thank you.
Complete thread:
- New FDA CDISC requirements for ANDAslechia 2016-09-19 21:37 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New FDA CDISC requirements for ANDAs DavidManteigas 2016-09-22 10:47
- New FDA CDISC requirements for ANDAs lechia 2016-11-22 22:33
- New FDA CDISC requirements for ANDAs DavidManteigas 2016-09-22 10:47
Ing. Helmut Schütz