Business considerations in the development of probiotics

Clinical Infectious Diseases

Volumn 46, Issue SUPPL. 2, 2008, Pages

  Hoffman, Freddie Ann ^a  

^a HeteroGeneity LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; PROBIOTIC AGENT;

CLINICAL MEDICINE; CONFERENCE PAPER; CONSUMER; DIET SUPPLEMENTATION; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; FOOD INDUSTRY; HEALTH PROMOTION; HUMAN; PACKAGING; PATENT; PRIORITY JOURNAL; SAFETY;

DRUG INDUSTRY; FOOD INDUSTRY; HEALTH FOOD; HUMANS; LEGISLATION, DRUG; LEGISLATION, FOOD; PROBIOTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40049085564     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523323     Document Type: Conference Paper

References (13)

1. Dietary Supplement Health and Education Act of 1994 [Public Law 103-417] [amended the FD & C Act, Section 411(c)(1)(B) (21 USC 350(c)(1)(B))].
2. US Food and Drug Administration. 21 CFR Parts 170, et al. Proposed rules: substances generally recognized as safe; proposed rule. Fed Reg 1997; 62:18937-64.
3. 21 CFR §190.6(b)(4).
4. 21 CFR §170.20.
5. US Food and Drug Administration. 21 CFR Part 330, et al. Final rule: additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Fed Reg 2002; 67:3060-76.
6. Federal Food, Drug and Cosmetic Act §201(p)(1).
7. Federal Food, Drug and Cosmetic Act §201(f)(1-3).
8. Federal Food, Drug and Cosmetic Act §201(g)(1)(b).
9. Public Health Service Act [42 USC §262(i)].
10. 21 CFR §314.126.
11. Drug Price Competition and Patent Term Restoration Act of 1984.
12. Public Health Service Act [42 USC §262(j)].
13. US Food and Drug Administration, Center for Biologics Evaluation and Research. Product approval information - licensing action. FDA letter to Organon Teknika Corporation, regarding a Supplement to license application 92-0306 for BCG Live (TICE BCG). 21 August 1998. Available at: http://www.fda.gov. Accessed 17 December 2007.