Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices

On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.

This guidance is intended to help clinical investigators comply with the following safety reporting requirements:

  • Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 312.64(b)
  • Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)

Recommendations are provided to help investigators identify the following:

  • For drugs — Identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) under § 312.66 (21 CFR 312.66
  • For devices — Identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs under § 812.150(a)(1) (21 CFR 812.150(a)(1))
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