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Safety Reports
  • Periods for submission of written and telephone reports extended to 15 and 7 calendar days respectively; faxes acceptable in lieu of telephone reports.

  • Form 3500A (same as proposed form for postmarketing reports) allowed.

  • Disclaimer to apply to all safety information so as not to constitute a statement or admission of a causal link between drug and a subsequent adverse event.

Semiannual Reports
  • Current annual death and serious adverse experiences report to be supplemented by semiannual reports; semiannual report not to take place of annual report.

  • Report all deaths, serious adverse experiences, and study discontinuations due to adverse experiences, whether or not unexpected, and whether or not caused by the study drug.

  • Data required from IND studies, worldwide premarketing studies, and foreign postmarketing trials or reporting systems.

  • Data to be presented cumulatively as well as for a 6-month period.

  • Worst case analysis of data required—presumption against drug then attempt to refute presumption.

  • Submission of all available autopsy reports and medical reports of deaths required; sponsor to clarify inconsistencies between reports and cause of death reported to FDA by the sponsor.

  • FDA may modify reporting requirements, e.g., when it would interfere with a blinded (masked) study, in which neither patients nor study staff are aware of which patients are receiving control treatment until the end of the trial.

Special Safety Summary
  • Data on events not defined as serious adverse reactions.

  • Agency to determine when it is needed and the information required.

  • Should contain results of cumulative analyses in other reports as well as analyses of lesser events.

  • Generally, 30 days from request to comply.

Final Clinical Study Report
  • FDA may require a final report or study summary of a study at its discretion.

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