Environmental assessment requirements for live biological drugs

Clinical Infectious Diseases

Volumn 46, Issue SUPPL. 2, 2008, Pages

  Sutton, Ann ^a,b  

^a Biologics Consulting Group   (United States)

^b Biologics Consulting Group Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; PROBIOTIC AGENT;

CONFERENCE PAPER; CONSUMER; DRUG APPROVAL; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; ENVIRONMENTAL IMPACT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; INFORMATION PROCESSING; POLLUTION; PRIORITY JOURNAL; UNITED STATES;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUG INDUSTRY; ENVIRONMENT; ENVIRONMENTAL MICROBIOLOGY; ENVIRONMENTAL MONITORING; FOOD INDUSTRY; HUMANS; PROBIOTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40049085401     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523330     Document Type: Conference Paper

References (3)

1. Food and drugs: environmental impact considerations. Code of Federal Regulations title 21 part 25. Washington, DC: Government Printing Office, 1 April 2006:5-86.
2. US Food and Drug Administration, Department of Health and Human Services. Guidance for industry: environmental assessment of human drugs and biologics applications. Available at: http://www.fda.gov/cber/gdlns/environ.pdf. Accessed July 2006.
3. Cassone M, Serra P, Mondello F, et al. Outbreak of Saccharomyces cerevisiae subtype boulardii fungemia in patients neighboring those treated with a probiotic preparation of the organism. J Clin Microbiol 2003; 41:5340-3.