FDA regulatory reform

Current Opinion in Biotechnology

Volumn 8, Issue 3, 1997, Pages 370-378

  Beatrice, Michael ^a  

^a Biopharmaceutical Consult Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; POLICY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW;

EID: 0030973567     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0958-1669(97)80019-5     Document Type: Article

References (22)

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11. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Points to Consider in Human Somatic Cell Therapy and Gene Therapy. Rockville: FDA; 1991.
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19. US Government: Interim Definition and Elimination of Lot-by-lot Release for Well Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products. Federal Register. Washington, DC: US Government Printing Office; 1995.
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