Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification on What to Report

Status: Final

Date: August 1997

Target Audience:

Industry required to report adverse experiences to the FDA, including:

  1. Applicants of approved new drug applications, abbreviated new drug applications, and antibiotic applications
  2. Manufacturers (including packers and distributors) of marketed prescription drugs for humans
  3. Licensed manufacturers of approved biologic license applications

Laws and Regulations:

  1. 62 FR 34166: Revoking of the postmarketing safety reporting requirement to submit expedited increased frequency reports for human drugs and licensed biological products.
  2. Guideline for Postmarketing Reporting of Adverse Drug Experiences: Postmarketing adverse event reporting
  3. Guidelines for Adverse Experience Reporting for Licensed Biological Products: Postmarketing adverse event reporting
  4. Code of Federal Regulations, title 21, 310.305, 314.80, 314.98, and 600.80: Data to be included in a safety report
  5. International Conference on Harmonisation (ICH) E2A document Guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (60 FR 11284)
  6. International Reporting of Adverse Drug Reactions: definition of International Reporting of Periodic Drug-Safety Update Summaries: definition of CIOMS Reportable Case histories (CIOMS Report): Minimum Standard of Information


This guidance provides recommendations to industry on how best to do postmarketing safety reporting, including what data must be gathered before an adverse experience should be submitted to the FDA and how to handle solicited safety information from patients. This guidance also encourages the use of waiver requests for periodic safety reports for adverse experiences that are classified “nonserious and labeled” (i.e., included in the labeling for marketed products).


More and more individual safety case reports are being submitted to the FDA without sufficient data for interpretation/evaluation. “Nonserious and labeled” adverse experiences are the fastest growing type of safety report to be submitted to the FDA. Guidance is needed to improve postmarketing safety reporting and to reduce the burden of safety reporting on industry without compromising public health.


The four following criteria should be obtained for each safety report, and safety reports without all criteria should not be submitted:

  1. an identifiable patient (identified by an assigned code, not name or address; with specific information, e.g., “an elderly woman”)
  2. an identifiable reporter
  3. a suspect drug/biological product
  4. an adverse event (at minimum: specific signs [including abnormal laboratory values], symptoms, or disease diagnosis)/fatal outcome (reporting required even if the adverse event is unknown)

Potential adverse experiences from planned contacts and active solicitation of information from patients (e.g., sponsored patient support programs, disease management programs) should not be submitted to the FDA unless an adverse event is classified “serious and unexpected” (see definitions for “serious adverse drug experience” and “unexpected adverse drug experience”) and is possibly reasonably related to the human drug or biological product.

Requests to waive reporting of “nonserious and labeled” postmarketing adverse experiences are encouraged for human drugs but not for new biological products within one year of approval or blood products, plasma derivatives, or vaccines.


Submission of postmarketing safety reports with insufficient data (e.g., “some patients had anaphylaxis”) and nonserious and known adverse events will be reduced. This will decrease the burden of safety reporting on industry and consequently decrease the corresponding workload of the FDA reviewers. With fewer and cleaner safety reports for the FDA to review, new and significant safety signals may be identified faster.

For more information on this issue, contact the Kulkarni Law Firm.