The ability of current biologics law to accommodate emerging technologies

Food and Drug Law Journal

Volumn 51, Issue 3, 1996, Pages 375-380

  Carter, Martha J ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; GENETIC RECOMBINATION; HISTORY; LAW; RECOMBINANT GENE; REVIEW;

BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; CELL TRANSPLANTATION; CONSUMER PRODUCT SAFETY; DRUG APPROVAL; FORECASTING; GENE THERAPY; HUMANS; LEGISLATION, DRUG; TRANSPLANTATION, HETEROLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029761759     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (26)

1. Coordinated Framework for the Regulation of Biotechnology, Office of Science and Technology Policy, 49 Fed. Reg. 50,856 (Dec. 31, 1984).
2. 51 Fed. Reg. 23,302 (June 26, 1986).
3. Id. at 23,310.
4. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301 et seq. (1994).
5. Pub. L. No. 57-244, 32 Stat. 728, ch. 1378 (1902); revised 58 Stat. 682, 702-03 (1944) (codified at 42 U.S.C. § 262 (1988)).
6. FOOD AND DRUG ADMIN., POINTS TO CONSIDER IN HUMAN SOMATIC CELL THERAPY AND GENE THERAPY 3 (1991).
7. FOOD AND DRUG ADMIN., DRAFT POINTS TO CONSIDER IN THE PRODUCTION AND TESTING OF NEW DRUGS AND BIOLOGICALS PRODUCED BY RECOMBINANT DNA TECHNOLOGY (1983 & 1985 update).
8. FOOD AND DRUG ADMIN., POINTS TO CONSIDER IN THE CHARACTERIZATION OF CELL LINES USED TO PRODUCE BIOLOGICAL PRODUCTS (1984, 1987 update, & 1993 update).
9. FOOD AND DRUG ADMIN., supra note 6.
10. FOOD AND DRUG ADMIN., POINTS TO CONSIDER IN THE MANUFACTURE AND TESTING OF THERAPEUTIC PRODUCTS FOR HUMAN USE DERIVED FROM TRANSGENIC ANIMALS (1995).
11. FOOD AND DRUG ADMIN., supra note 7, at 13.
12. Martha J. Carter, Practical Points to Consider From the Manufacturer's Perspective in Developing Recombinant Products, 1 REG. AFF. 111 (1989).
13. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products, 58 Fed. Reg. 53,248 (Oct. 14, 1993).
14. Id. at 53,250.
15. Id. at 53,251.
16. Id. at 53,248.
17. Id. In 1993, the FDA published an interim rule to require certain infectious disease testing, donor screening, and record keeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. See 58 Fed. Reg. 65,514 (Dec. 14, 1993).
18. Louisa E. Chapman, Thomas M. Folks, Daniel R. Salomon, Amy P. Patterson, Thomas E. Eggerman & Philip D. Noguchi, Xenotransplantation and Xenogeneic Infections, 333 NEW ENG. J. MED. 1498 (1995).
19. FDA Eyes ELA as Foundation for Unique Reg Plan for Tissue Products, FDA WEEK, Nov. 17, 1995, at 1.
20. Mouse Prepares to Lend an Ear, BOSTON GLOBE, Oct. 25, 1995, at 9.
21. Philip D. Noguchi, Regulatory Issues Involving Gene Therapy, Cell Therapy and Ancillary Reagents: The Wave of the Future, Speech at The Food and Drug Law Institute's Biologies Update '95, Washington, D.C. (July 24, 1995).
22. See also Philip D. Noguchi, From Jim to Gene and Beyond: An Odyssey of Biologies Regulation, 51 FOOD & DRUG L.J. 367 (1996).
23. Regulatory Issues, supra note 21.
24. FOOD AND DRUG ADMIN., TRANSCRIPT OF ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEETING (Sept. 10-11, 1984).
25. Paul Brown, D. Carleton Gajdusek, C.J. Gibbs & David M. Asher, Potential Epidemic of Creutzfeldt-Jakob Disease from Human Growth Hormone Therapy, 313 NEW ENG. J. MED. 728 (1985).
26. JAMES WATSON, ANNUAL REPORT, COLD SPRING HARBOR LABORATORY (1976), quoted in CELL SUBSTRATES - THEIR USE IN THE PRODUCTION OF VACCINES AND OTHER BIOLOGICALS 2 (John C. Petricciani, Hope E. Hopps & Paul J. Chapple, eds., 1979).