Guidance On Completing Fda Form 1571 printable pdf download

Guidance On Completing Fda Form 1571

Guidance on completing FDA Form 1571

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

[insert

reference])

Parts 2-4 can be addressed in the form of a cover letter; however, the sponsor is expected to provide some background information about FMT.

It does not need to be an exhaustive review of the literature, but should provide the FDA with a rationale behind the proposed treatment with

citations of relevant literature supporting its use. For example: “The concept of FMT is to restore the fecal microbiologic diversity of a patient

with CDI by directly instilling fecal material collected from a healthy donor. This has been proven effective in numerous case reports and

1,2

retrospective case series

in patients with recurrent CDI resulting in superior cure rates compared to previously reported cure rates with

standard therapy. Most recently, an open-label, randomized, controlled trial directly comparing FMT with two different antibiotic regimens

clearly demonstrated the superiority of FMT in patients with recurrent CDI

”.

Bakken JS. Fecal bacteriotherapy for recurrent Clostridium difficile infection. Anaerobe 2009 Sep 22; 15(6):285-9

Petrof EO, Gloor GB, Vanner SJ, et al. Stool substitute transplant therapy for the eradication of Clostridium difficile infection: "RePOOPulating the gut.

Microbiome 2013;1(1):3-10

Van Nood E, Vrieze A, and Nieuwdorp M: Duodenal infusion of donor feces for recurrent Clostridium difficile. NEJM 2013;368:407-415.

Guidance On Completing Fda Form 1571

Related Articles

Related forms

Related Categories