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RegisterNew FDA CDISC requirements for ANDAs [Regulatives / Guidelines]
Thank you for your response, David.
A related question is whether pilot studies that are submitted to the FDA along with the pivotal studies for information/completeness purposes must also follow CDISC standards. The guidance says:
"... all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies ... for NDA, ANDA, and certain BLA submissions."
Not sure how to interpret this. Would only pivotal studies fit this description or any study since any study done on a particular IP since it would be part of the submission? Presumably this would not matter if a study is ANDA or NDA.
Thanks.
A related question is whether pilot studies that are submitted to the FDA along with the pivotal studies for information/completeness purposes must also follow CDISC standards. The guidance says:
"... all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies ... for NDA, ANDA, and certain BLA submissions."
Not sure how to interpret this. Would only pivotal studies fit this description or any study since any study done on a particular IP since it would be part of the submission? Presumably this would not matter if a study is ANDA or NDA.
Thanks.
Complete thread:
- New FDA CDISC requirements for ANDAs lechia 2016-09-19 21:37
![[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 ANDAslechia 2016-11-22 22:33
- New FDA CDISC requirements for ANDAs DavidManteigas 2016-09-22 10:47
Ing. Helmut Schütz