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RegisterCritical dose drugs - FDA highly variable NTID [Regulatives / Guidelines]
Dear Nirav,
again: If you aimed a submission in Canada follow my hint.
What you cite as "OGD for rivaroxaban" is FDA recommended evaluation method. Follow it if you aim for an FDA submission.
If you aim for an EMA submission follow the EMA recommendations.
Other regulatory bodies may have different recommendations. Follow them if you aim for a submission to them.
Simple. Isn't it?
again: If you aimed a submission in Canada follow my hint.
What you cite as "OGD for rivaroxaban" is FDA recommended evaluation method. Follow it if you aim for an FDA submission.
If you aim for an EMA submission follow the EMA recommendations.
Other regulatory bodies may have different recommendations. Follow them if you aim for a submission to them.
Simple. Isn't it?
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
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- Critical dose drugs d_labes 2017-04-24 11:26
Ing. Helmut Schütz