Guidance On Completing Fda Form 1571 (Page 2 of 4) in pdf

Guidance On Completing Fda Form 1571 Page 2

Guidance on completing FDA Form 1571 (cont’d)

(Taken from “Fecal Microbiota Transplantation: A Practical Update for the Infectious Disease Specialist” –

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reference])

Part 5 (Investigator’s Brochure): Creation of a brochure will be necessary if the applicant plans to conduct the study at multiple sites, and a copy

will need to be submitted with the IND to the FDA. A brochure is not required for emergency INDs. The purpose of the brochure is to provide

co-investigators involved in the trial with the information necessary to participate and should include—in lieu of the treatment protocol, if

desired—a brief summary, introductory statement, background of the disease, summary of known safety and efficacy data, description of the

product, proposed indications, dosing form/regimen, route of planned administration, description of the instillation technique, and other

information about the clinical trial (i.e., data to be gathered, time-points, endpoints, etc.). The brochure should be reviewed annually and

revised when necessary to include any new relevant information.

Guidance On Completing Fda Form 1571 Page 2