Executive summary: Scientific and regulatory challenges of development of probiotics as foods and drugs

Clinical Infectious Diseases

Volumn 46, Issue SUPPL. 2, 2008, Pages

  Hoffman, Freddie Ann ^a   Heimbach, James T ^b   Sanders, Mary Ellen ^c   Hibberd, Patricia L ^d,e  

^a HeteroGeneity LLC   (United States)

^b JHeimbach LLC   (United States)

^c International Scientific Association for Probiotics and Prebiotics   (United States)

^d TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e TUFTS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROBIOTIC AGENT;

ADAPTIVE IMMUNITY; CONFERENCE PAPER; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG MECHANISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; INNATE IMMUNITY; INTESTINE FLORA; MEDICAL INFORMATION; MEDICAL RESEARCH; PRIORITY JOURNAL; SCIENCE; UNITED STATES;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; DRUG INDUSTRY; FOOD INDUSTRY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; PROBIOTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40049103741     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523342     Document Type: Conference Paper

References (6)

1. Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. Guidelines for the evaluation of probiotics in food: report of a Joint FAO/WHOWorking Group on Drafting Guidelines for the Evaluation of Probiotics in Food, London, Ontario, Canada, April 30 and May 1, 2002. Available at: http://www.who.int/foodsafety/publications/fs_management/probiotics2/en/ index.html. Accessed 18 May 2007.
2. Agheyisi R. Reports and reviews - probiotics: ingredients, supplements, foods. BCC Research Report ID FOD035A. July 2005. Available at: http: //www.bccresearch.com. Accessed 17 December 2007.
3. Department of Health and Human Services. Probiotics for pediatric illnesses (R21). 5 March 2006. Available at: http://grants.nih.gov/ grants/guide/pa-files/PA-06-316.html. Accessed 18 May 2007.
4. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001; 134:657-62.
5. Federal Food, Drug and Cosmetic Act §201(p)(1) [21 USC 321(p)(1)].
6. Center for Drug Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. Guidance for industry: botanical drug products. June 2004. Available at: http://www.fda.gov/cder/guidance/ 4592fnl.pdf. Accessed 18 May 2007.