Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies

Clinical Gastroenterology and Hepatology

Volumn 12, Issue 2, 2014, Pages 283-288

  Kelly, Colleen R ^a   Kunde, Sachin S ^b   Khoruts, Alexander ^c  

^a BROWN UNIVERSITY   (United States)

^b MICHIGAN STATE UNIVERSITY   (United States)

^c UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

Author keywords

CBER; FDA

Indexed keywords

ARTICLE; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM DIFFICILE INFECTION; DRUG APPROVAL; FECAL MICROBIOTA TRANSPLANTATION; FECES MICROFLORA; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TRACT FUNCTION; HUMAN; NONHUMAN; PATIENT SAFETY; RECURRENT INFECTION; RISK BENEFIT ANALYSIS; TREATMENT INDICATION; TREATMENT OUTCOME;

ADVERSE EVENT; AE; CASE REPORT FORM; CBER; CDI; CENTER FOR BIOLOGICS EVALUATION AND RESEARCH; CLOSTRIDIUM DIFFICILE INFECTION; CRF; FDA; FECAL MICROBIOTA TRANSPLANTATION; FMT; FOOD AND DRUG ADMINISTRATION; HIV; HUMAN IMMUNODEFICIENCY VIRUS; IB; IBD; IC; IND; INFLAMMATORY BOWEL DISEASE; INFORMED CONSENT; INSTITUTIONAL REVIEW BOARD; INVESTIGATIONAL NEW DRUG; INVESTIGATOR'S BROCHURE; IRB; R-CDI; RECURRENT CDI; SAE; SERIOUS ADVERSE EVENT;

BIOLOGICAL THERAPY; CLINICAL PROTOCOLS; CLOSTRIDIUM DIFFICILE; ENTEROCOLITIS, PSEUDOMEMBRANOUS; FECES; HUMANS; INTESTINES; INVESTIGATIONAL NEW DRUG APPLICATION; MICROBIOTA; RECURRENCE; SPECIMEN HANDLING; TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84892482218     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cgh.2013.09.060     Document Type: Article

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