FDA Issues Two Guidance Documents to Help Sponsors with Safety Reporting Requirements

In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies as part of their responsibility to protect the rights, safety, and welfare of study participants.” This guidance can be found here. It provides information from previous safety reporting guidances consolidated into one document in order to assist stakeholders in referencing key information.

“The second guidance titled Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated under an IND, or as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements.” This second guidance can be found here.

Both guidances provide comprehensive advice for proper adverse event reporting in clinical studies, INDs, and in bioequivalence and bioavailability studies. There are some portions of overlap between the guidances but together they provide a fantastic review and outline of sponsor responsibilities. The FDA explains the rationale for the requirements as well as what, when, and how reports should be made.