From Jim to gene and beyond: An odyssey of biologics regulation

Food and Drug Law Journal

Volumn 51, Issue 3, 1996, Pages 367-374

  Noguchi, Philip D ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; EXPRESSION VECTOR; GENE THERAPY; HUMAN; LAW; MEDICAL TECHNOLOGY; NONHUMAN; REVIEW;

BIOLOGICAL PRODUCTS; CELL TRANSPLANTATION; GENE THERAPY; HUMANS; TRANSPLANTATION, HETEROLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029757693     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. See 21 U.S.C. § 321(g)(1), (h) (1994); 42 U.S.C. § 262(a) (1994).
2. 21 C.F.R. § 3.2 (1995).
3. Margaret Pittman, The Regulation of Biological Products, 1902-1970, in NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASE: INTRAMURAL CONTRIBUTIONS, 1887-1987, at 61 (H.R. Greenwald & V.A. Harden, eds., Dep't of Health & Human Servs. 1987).
4. Pub. L. No. 57-244, 32 Stat. 328 (1902). This Act also has been identified as the Virus Act, the Biologies Act, and the Serum Law.
5. Pub. L. No. 85-410, 58 Stat. 702 (1944).
6. Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (1906).
7. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301 et seq. (1988 & Supp. 1995).
8. Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962).
9. Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Products, 61 Fed. Reg. 24,227 (May 14, 1996).
10. FOOD & DRUG ADMIN., POINTS TO CONSIDER IN HUMAN SOMATIC CELL THERAPY AND GENE THERAPY (1991).
11. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products, 58 Fed. Reg. 53,248 (Oct. 14, 1993).
12. Id. at 53,259.
13. Source of these statistics is an internal database maintained by the FDA.
14. Id.
15. 60 Fed. Reg. 20,726 (Apr. 27, 1995).
16. Briefing Document for Biological Response Modifiers Advisory Committee; Availability, 61 Fed. Reg. 5786 (Feb. 14, 1996). See also FOOD & DRUG ADMIN., supra note 10.
17. See HOUSE APPROPRIATIONS COMMITTEE REPORT (1994).
18. 58 Fed. Reg. at 53, 248.
19. M.R. Brittberg, et al., Treatment of Deep Cartilage Defects in the Knee with Autologous Chondrocyte Transplantation, 331 NEW ENG. J. MED. 889 (1994).
20. The use of a single biologics license application is discussed in more detail in 61 Fed. Reg. at 24,227.
21. Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or Reconstruction; Availability, 61 Fed. Reg. 26,523 (May 28, 1996).
22. See 58 Fed. Reg. at 53,248.