Skip to main content
SpringerLink
Log in

An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products

  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

An index is provided covering relevant sections of Title 21, Code of Federal Regulations governing the safety surveillance of biological products which are required of manufacturers in the United States. This index also covers relevant guidelines published by the United States Food and Drug Administration.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Title 21 Code of Federal Regulations. 600.80. Washington, DC: U.S. Government Printing Office; 1995.

  2. Guideline for Adverse Experience Reporting for Licensed Biological Products. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; October 15, 1993.

Download references

Author information

Authors and Affiliations

  1. Regulatory Affairs and Pharmacovigilance, Fujisawa USA, Three Parkway North, Inc., Deerfield, Illinois, 60015-2548, USA

    Charles F. Curran PhD (Associate Director)

  2. Product Safety Surveillance and Information, Warner-Lambert Company, Morris Plains, New Jersey, USA

    Judith M. Sills PharmD (Senior Director)

Authors
  1. Charles F. Curran PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Judith M. Sills PharmD
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Curran, C.F., Sills, J.M. An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products. Ther Innov Regul Sci 31, 843–847 (1997). https://doi.org/10.1177/009286159703100324

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286159703100324

Key Words

Search

Navigation