Advertisement

Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling

  • Michael R. Hamrell
Article

Abstract

Safety reporting and postmarketing surveillance is one of the most important responsibilities of a manufacturer following approval of a new drug. New drug products are approved and placed on the market in the United States under the Federal Food Drug and Cosmetic (FD&C) Act. The FD&C Act allows for the approval of drugs that are safe and effective as determined by appropriate experts, qualified by training and experience to make such determinations. Following approval, the sponsor of each drug product is required to collect, monitor, and report to the Food and Drug Administration on all significant new developments with the drug product, including but not limited to, adverse drug experiences received by the company regarding the product. The collection, review, reporting, and assessment of this safety experience information has a great impact on the labeling for a product and the information provided to practitioners on a continuing basis regarding the safe use of a product. Thus, new safety information and the company’s reaction to this information is very important in providing accurate and up-to-date information to medical practitioners.

Key Words

Adverse experience Safety Labeling requirements 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    FDA Code of Federal Regulations. Subpart B, Postmarketing reporting for adverse drug experiences 314.80.Google Scholar
  2. 2.
    FDA Code of Federal Regulations. Subpart B, Other Postmarketing reports 314.81(b).Google Scholar
  3. 3.
    FDA Code of Federal Regulations. Subpart D, Postmarketing reporting of adverse experiences 600.80.Google Scholar
  4. 4.
    FDA Code of Federal Regulations. Subpart C, Postmarketing reports 314.98.Google Scholar
  5. 5.
    Food and Drug Administration. Expedited Safety Reporting Requirements for Human Drug and Biological Products: Final Rule, 62 FR 52237 Rockville, MD: Food and Drug Administration; October 7, 1997.Google Scholar
  6. 6.
    Johnson JM. Reasonable possibility: Causality and postmarketing surveillance. Drug Inf J. 1992:26:553–558.CrossRefGoogle Scholar
  7. 7.
    Food and Drug Administration. Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports, 62 FR 34166. Rockville, MD: Food and Drug Administration; June 25, 1997.Google Scholar
  8. 8.
    Food and Drug Administration. Guideline for Post-Marketing Reporting of Adverse Drug Experiences. Rockville, MD: Food and Drug Administration; March 1992.Google Scholar
  9. 9.
    Kessler DA, et. al. Introducing MedWatch. J Clin Res Drug Dev. 1993;269:183–190.Google Scholar
  10. 10.
    Britt AL. Safety Information Processing at the FDA. Drug Inf J. 1996;30:47–58.CrossRefGoogle Scholar
  11. 11.
    Center for Drug Evaluation and Research. CDER Report to the Nation, 1998. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research; 1997.Google Scholar
  12. 12.
    Department of Health and Human Services Inspector General Report. Review of the Food and Drug Administration’s Handling of Adverse Drug Reaction Reports. Washington, DC: U.S. Department of Health and Human Services; December 1999.Google Scholar
  13. 13.
    Flannery EJ. Reporting Foreign ADRs and ADRs in Phase IV studies, and the Significance of Causality Assessment. Food Drug Cosmetic Law J. 1991;46:43–57.Google Scholar
  14. 14.
    Electronic Reporting of Postmarketing Adverse Drug Reactions; Request for Comments, 63 FR: 59746–59750, 1998.Google Scholar
  15. 15.
    FDA Code of Federal Regulations. Subpart B, IND safety reports 312.32.Google Scholar
  16. 16.
    FDA Code of Federal Regulations. Subpart B, General requirements on content and format of labeling for human prescription drugs 201.56.Google Scholar
  17. 17.
    FDA Code of Federal Regulations. Subpart B, Specific requirements on content and format of labeling for human prescription drugs 201.57.Google Scholar
  18. 18.
    FDA Code of Federal Regulations. Prescription drug advertisements 202.1.Google Scholar
  19. 19.
    FDA Code of Federal Regulations. Subpart B, Specific requirements on content and format of labeling for human prescription drugs 210.57.Google Scholar
  20. 20.
    FDA Code of Federal Regulations. Subpart B, Supplements and other changes to an approved application 314.70.Google Scholar
  21. 21.
    FDA Code of Federal Regulations. Subpart A, Mailing of important information about drugs 200.5.Google Scholar

Copyright information

© Drug Information Association, Inc 2000

Authors and Affiliations

  • Michael R. Hamrell
    • 1
  1. 1.MORIAH ConsultantsYorba LindaUSA

Personalised recommendations