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D ER A E RS CHOICE O T S E THE BL L O R R A C Y T NU O C N IN T H A N UA L THE8 1 2N0 NERBARESULTSM c K E N Z I E BA N E R S P E C I A L E D I T I O N A P R I L 2 0 1 9Page 2 The McKenzie Banner 2018
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What is der?
Der stands for Drug Efficacy Review.
Who is required to file der?
Manufacturers and sponsors of new drugs are required to file der.
How to fill out der?
Der is filled out by providing detailed information about the efficacy of a new drug.
What is the purpose of der?
The purpose of der is to evaluate and demonstrate the effectiveness of a new drug.
What information must be reported on der?
Der must include data on clinical trials, patient outcomes, and any adverse effects reported.
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