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RegisterFDA requirement for Safety data for ANDAs SDTM [Regulatives / Guidelines]
Hi Sriraj,
Not surte if I understood your question.
According to FDA guidance, all data collected should be submitted, either safety, efficacy or other. Maybe you're talking about the datasets for the module 2.7. Not sure if, under the new requirements for data submission for ANDAs, those datasets should be submitted anyway. I would submit them anyway.
Regards,
David
Not surte if I understood your question.
According to FDA guidance, all data collected should be submitted, either safety, efficacy or other. Maybe you're talking about the datasets for the module 2.7. Not sure if, under the new requirements for data submission for ANDAs, those datasets should be submitted anyway. I would submit them anyway.
Regards,
David
Complete thread:
- FDA requirement for Safety data for ANDAs SDTM Sriraj 2016-11-25 10:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA requirement for Safety data for ANDAs SDTMDavidManteigas 2016-11-26 19:09
- FDA requirement for Safety data for ANDAs SDTM Sriraj 2016-12-01 10:28
- FDA requirement for Safety data for ANDAs SDTM DavidManteigas 2016-12-02 10:22
- FDA requirement for Safety data for ANDAs SDTM Sriraj 2016-12-01 10:28
- FDA requirement for Safety data for ANDAs SDTMDavidManteigas 2016-11-26 19:09
Ing. Helmut Schütz