Advancing probiotic research in humans in the United States: Challenges and strategies

Gut Microbes

Volumn 7, Issue 2, 2016, Pages 97-100

  Sanders, Mary Ellen ^a   Shane, Andi L ^b   Merenstein, Daniel J ^c  

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

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

CBER; CFSAN; FDA; probiotic; regulatory

Indexed keywords

PROBIOTIC AGENT;

DIET SUPPLEMENTATION; FOOD AND DRUG ADMINISTRATION; GENETIC STRAIN; HUMAN; MARKET; MEDICAL RESEARCH; NOTE; SAFETY; UNITED STATES; DIETARY SUPPLEMENT; DRUG LEGISLATION; FOOD; LAW; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; STANDARDS; TRENDS;

BIOMEDICAL RESEARCH; DIETARY SUPPLEMENTS; FOOD; HUMANS; LEGISLATION, DRUG; LEGISLATION, FOOD; PROBIOTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84961208299     PISSN: 19490976     EISSN: 19490984     Source Type: Journal    
DOI: 10.1080/19490976.2016.1138198     Document Type: Note

References (6)

1. P.L.Hibberd, L.Kleimola, A.M.Fiorino, C.Botelho, M.Haverkamp, I.Andreyeva, D.Poutsiaka, C.Fraser, G.Solano-Aguilar, D.R.Snydman. No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. PLoS One 2014 Dec 1; 9(12):e113456. eCollection 2014; http://dx.doi.org/10.1371/journal.pone.0113456
2. D.J.Merenstein, T.P.Tan, A.Molokin, K.H.Smith, R.F.Roberts, N.M.Shara, M.Mete, M.E.Sanders, G.Solano-Aguilar. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study. Gut Microbes 2015; 6(1):66-77; PMID:25569274; http://dx.doi.org/10.1080/19490976.2015.1005484
3. Food and Drug Administration. 2013. Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM229175.pdf AccessedSeptember24, 2015.
4. Food and Drug Administration. 2014. Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period. https://www.federalregister.gov/articles/2014/02/06/2014-02550/guidance-for-clinical-investigators-sponsors-and-institutional-review-boards-on-investigational-new. AccessedOctober7, 2015.
5. Food and Drug Administration. 2007. Food and Drug Administration Amendments Act of 2007; Prohibition Against Food to Which Drugs or Biological Products Have Been Added Section 912 Food, Drug, and Cosmetic Act section 301(ll). http://www.fda.gov/ohrms/dockets/98fr/cf0826.pdf. Accessed October7, 2015.
6. Food and Drug Administration. 2015 Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Request for Comments Federal Register Notice, https://www.federal/register.gov/articles/2015/03/31/2015-07273/early-clinical-trials-with-live-biotherapeutic-products-chemistry-manufacturing-and-control. AccessedSeptember24, 2015.