Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs

On 19 May 2021 the FDA published the draft guidance on questions regarding the Statement of Investigator Form 1572.

This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application (IND) regulations) and describes how to complete the Statement of Investigator (Form FDA 1572).

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