Industry view on the regulation of ancillary reagents

Food and Drug Law Journal

Volumn 51, Issue 1, 1996, Pages 155-159

  Schifreen, Richard S ^a   Louth, Cynthia ^a  

^a Life Technologies Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXCIPIENT;

DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; LAW; REVIEW;

DEVICE APPROVAL; GENE THERAPY; HUMANS; INDICATORS AND REAGENTS; INDUSTRY; LEGISLATION, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030010379     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products, 58 Fed. Reg. 53,248 (Oct. 14, 1993).
2. Pub. L. No. 75-717, § 201(h), 52 Stat. 1040, 1041 (1938), as amended 21 U.S.C. § 321(h) (1988).
3. 21 C.F.R. § 801.4 (1995).
4. CBER, Public Meeting in conjunction with the Recombinant DNA Advisory Committee Meeting, National Institutes of Health, Bethesda, Md. (Mar. 6, 1995).
5. Human Tissue Intended for Transplantation; Interim Rule, 58 Fed. Reg. 65,514 (Dec. 14, 1993).
6. Pub. L. No. 98-507, 98 Stat. 2339 (1984).
7. Washington Legal Foundation v. David Kessler and Donna Shalala, No. 94-1306(RCL) (D.D.C. Mar. 9, 1995). See also Robert P. Charrow, Now the Food and Drug Administration Regulates Free Speech, 7 J. NIH RESEARCH, July 1995, at 90-92.
8. Gail Dutton, Off-Label Drug Usage Laws Gain Momentum, 15 GENETIC ENGINEERING NEWS, Jan. 15, 1995, at 1.
9. Ricki Lewis, New Antibody Classification May Restrict Research, 14 GENETIC ENGINEERING NEWS, Nov. 15, 1994, at 1.
10. Pub. L. No. 100-578, 102 Stat. 2903 (codified at 42 U.S.C. §§ 201 note, 263a, 263a note (1988)).
11. Lee Tune, Proposed "Home-Brew" Test Restrictions Anger Labs, 18 CLINICAL CHEMISTRY NEWS, Nov. 1992, at 1.
12. Sue Auxter, FDA Clarifies Policy on "Home-Brew" Testing, 21 CLINICAL LABORATORY NEWS, Mar. 1995, at 1.
13. FOOD & DRUG ADMIN., FDA COMPLIANCE POLICY GUIDE, SF: IVDs - DRAFT (Aug. 1992).
14. Statement by Steven Gutman, Dir., Clinical Laboratory Devices, Center for Devices and Radiological Health, FDA, at The Food and Drug Law Institute's Videoconference "In Vitro Diagnostics," Rockville, Md. (Jan. 19, 1995); see also Auxter, supra note 11.