Investigational Products

There are several guidances/guidelines applicable to the review and reporting of adverse events prior to product approval. The most important, but not all, of these guidances are

• ICH, Guidance on Data Elements for Transmission of Individual Case Safety Reports (1998)

• ICH, Guideline for Industry—E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (1995)

The first guidance addresses issues such as the specific and minimal data necessary or advisable for reporting of adverse events to the FDA. The second guidance addresses issues including how to manage blinded studies, adverse reactions occurring on placebo, reporting time frames, and post-study events.

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