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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 312 — INVESTIGATIONAL NEW DRUG APPLICATION
Subpart D — Responsibilities of Sponsors and Investigators
Federal (United States) · Regulations
Subpart D — Responsibilities of Sponsors and Investigators
5 sections
5 sections
21 C.F.R. § 312.55
Informing investigators.
21 C.F.R. § 312.56
Review of ongoing investigations.
21 C.F.R. § 312.57
Recordkeeping and record retention.
21 C.F.R. § 312.58
Inspection of sponsor's records and reports.
21 C.F.R. § 312.59
Disposition of unused supply of investigational drug.
Subpart D — Responsibilities of Sponsors and Investigators | Federal (United States) Regulations | Justis AI