Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Technology Report
  • Published:

Regulatory Trends for Biotechnology Products

Bio/Technology volume 1, pages 240–246 (1983)Cite this article

Access through your institution
Buy or subscribe

This is a preview of subscription content, access via your institution

Access options

Access through your institution

Buy this article

  • Purchase on SpringerLink
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Korwek, E.L. 1981. OSHA Regulation of Industrial Applications of Recombinant DNA Technology. U. Cinn. L. Rev. 50: 284.

    Google Scholar 

  2. Nutrilab, Inc. v. Schweiker. 1982. Food Drug Cosm. L. Rep. (CCH) ¶ 38,188 (N.D. Ill. 1982).

  3. FD&C Act, 1976. § 201(g)(1)(C), 21 U.S.C. § 321(g)(1)(C).

  4. Biotics Research Corp. v. Schweiker. 1982. Food Drug Cosm. L. Rep. (CCH) ¶ 38,160 (D. Nev. 1982).

  5. Korwek, E.L. 1982. FDA Regulation of Biotechnology as a New Method of Manufacture. Food Drug Cosm. L. J. 37: 289.

    Google Scholar 

  6. Korwek, E.L. and Trinker, D. 1981. Perspectives on the FDA Status of Drug Products Manufactured by the Recombinant DNA Technique. Food Drug Cosm. L. J. 36: 517.

    Google Scholar 

  7. Fed. Reg. 47: 26,458 (June 18, 1982).

  8. Korwek, E.L. 1983. USDA's Role in Regulating Biotechnology: Growing Daily. Biotechnology and the Law Conference, Keller and Heckman, Washington, D.C.

    Google Scholar 

  9. United States v. Generix Drug Corp., slip op. at 8 (Mar. 22, 1983).

  10. 5 Recombinant DNA Technical Bulletin 177 (1982).

  11. Korwek, E.L. 1982. FDA, OSHA and EPA Regulation of the Recombinant DNA Technology. J. Parenteral Sci. and Tech. 26: 251, 253–55.

    Google Scholar 

Download references

Author information

Author notes

  1. Edward L. Korwek: He was chairman of the conference “Biotechnology and the Law: Regulatory Strategies for Marketing Biotechnology-Derived Products.”

Authors and Affiliations

  1. Ph.D., J.D., is associated with the law offices of Keller & Heckman, Washington, D.C.

    Edward L. Korwek

Authors
  1. Edward L. Korwek
    View author publications

    Search author on:PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Korwek, E. Regulatory Trends for Biotechnology Products. Nat Biotechnol 1, 240–246 (1983). https://doi.org/10.1038/nbt0583-240

Download citation

  • Issue date:

  • DOI: https://doi.org/10.1038/nbt0583-240

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing