FDA Policy/General

2 Guides Posted on Product Safety Reporting

FDA has released two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and IDE studies.

The first guidance, “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices,” provides recommendations to help investigators identify drug-related serious adverse events that must be immediately reported to the sponsor and drug safety information that is considered an unanticipated problem involving risk to human participants or others and, therefore, requires prompt reporting to IRBs. For devices, it provides recommendations on safety information that meets the requirements for reporting unanticipated adverse device effects to sponsors and IRBs.

This guidance also provides information on investigator review of IND safety reports received from sponsors, reports of safety information from IND-exempt BA/BE studies received from persons conducting the studies, and unanticipated adverse device effect reports received from sponsors.

The second guidance, “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies,” provides interpretations of terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors. To facilitate appropriate IND safety reporting practices, the document also provides recommendations related to the two IND safety reporting provisions (§ 312.32(c)(1)(i)(C) and (c)(1)(iv)) that require assessment of aggregate data.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome