Development of probiotics as biologic drugs

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

BCG VACCINE; DIPHTHERIA ANTIBODY; PROBIOTIC AGENT;

CONFERENCE PAPER; DRUG APPROVAL; DRUG CONTAMINATION; DRUG EFFICACY; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH PRACTITIONER; HUMAN; LEGAL ASPECT; PRESCRIPTION; PRIORITY JOURNAL; RISK; TETANUS;

ANIMALS; BIOLOGICAL PRODUCTS; CLINICAL TRIALS AS TOPIC; CONSUMER PRODUCT SAFETY; DRUG APPROVAL; DRUG LABELING; HUMANS; PROBIOTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40049083983     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523326     Document Type: Conference Paper

References (18)

1. US Food and Drug Administration home page. Available at: http:// www.fda.gov.
2. Federal Biologics Control Act of 1902.
3. Pure Food and Drugs Act of 1906 [Public Law No. 59-384]. 34 STAT. 768 (1906) 21 USC Sec 1-15 (1934) (Repealed in 1938 by 21 USC Sec 329 (a)). Available at: http://www.fda.gov/opacom/laws.
4. Federal Food, Drug and Cosmetic Act of 1938, as amended. [US Code, Title 21, Chapter 9].
5. Federal Food, Drug and Cosmetic Act §201(g)(1)(B) [21 USC 321(g)(1)(B)].
6. Federal Food, Drug and Cosmetic Act §201(p)(1) [21 USC 321(p)(1)].
7. Federal Food, Drug and Cosmetic Act of 1962 Section 505(D), as amended.
8. Public Health Services Act of 1944 (42 USC 201 Chapter 6A - Public Health Service), as amended.
9. Public Health Service Act [42 USC §262].
10. Office of Vaccine Research and Review Working Group, Center for Biologics Evaluation and Research, US Food and Drug Administration.
11. Title 21 Code of Federal Regulations, Part 312. [Investigational New Drug Application].
12. Lepay DA. Emerging issues in FDA's oversight of clinical research. Presented at the Food and Drug Administration Science Board Meeting, 16 November 2001. Available at: http://www.fda.gov/ohrms/dockets/ac/01/slides/ 3799s1.htm.
13. Standard language from FDA Warning Letters. Available at: http://www.fda.gov/foi/warning.htm.
14. Title 21 Code of Federal Regulations, Part 600.3 [Biologic product requirements].
15. Bhattacharyya SP. Regulatory considerations - product development, preclinical testing and toxicity issues. Presented at the 46th Annual Meeting of the Drug Information Association (Philadelphia), 2006.
16. Federal Food, Drug & Cosmetic Act (21 USC 301 et seq.).
17. Hardegree MC, Center for Biologics Evaluation and Research, US Food and Drug Administration. Letter to Clement TS, Organon Teknika Corporation, regarding the approval of the supplement to its license application for BCG Live (TICE BCG). 21 August 1998. Available at: http://www.fda.gov/cber/ approvltr/bcgorga082198L.htm.
18. Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. [Public Law 109-462, 120 Stat. 3469].