Get Fda Form 766

Form FDA 766 - Application for Authorization to Relabel or Recondition Non-Compliant Articles (PDF)

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

The Notice of FDA Action: Advises that the entry is to be held for an FDA examination or sampling; and, Specifies the items (lines) in the entry that need be held.

The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.

Reconditioned food means packaged distressed food which is distributed or offered for sale as human food after its package is repaired or relabeled without being opened.

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

When a new investigator is added to the study (21 CFR 312.53(c)). It must be completed and signed before an investigator can participate in a clinical investigation. in section #9 of the Form FDA 1572.