Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017

Judit Milstein describes practical aspects of the IND submission and the sponsor’s and agency’s expectations during the first 30days after the initial IND submission. She also describes the grounds and procedures for imposition of a clinical hold, including practical aspects of this notification and subsequent steps to provide for the lifting of the clinical hold.
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