Will the Clinical Development Program Be Adequate for Regulatory Approval

Will the Clinical Development Program Be Adequate for Regulatory Approval  

In addition/ the following clinical/regulatory questions are representative of those that need to be considered in designing a clinical development plan to meet U.S. regulatory requirements  

NDA/BLA is hied. Priority reviews are to be reviewed within 6 months of the hling date. 

Drug development is as much an art as a science. We are trained in various professions such as biology/ pharmacology/ chemistry/ medicine/ biostatis-ticS/ computer science/ etc./ but rarely does a university offer a course/ yet alone a curriculum/ in drug development. 

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