Regulation Text
Authority
21 U.S.C. 321,343,346,346a,348,350a,350b,351,352,353,355,360,360c-360f,360h,360i,360j,360hh-360ss,371,379e,381;42 U.S.C. 216,241,262.
Related Guidelines (9)
Cooperative Research: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
→CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
→Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry (Status: Final)
→Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
→IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
→Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Status: Final)
→IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
→COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
→Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry (Status: Final)
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