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FDA Issues Two Guidances on Safety Reporting Requirements and Safety Assessments
Today, the U.S. Food and Drug Administration issued two final guidances, “Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices” and “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”
The first guidance 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. The guidance also streamlines and incorporates information from previous guidances to aid stakeholders in easily referencing key information.
The second guidance 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.
These two final guidances published today replace the recommendations for investigators and sponsors to comply with safety reporting requirements previously provided in the final guidance documents “Safety Reporting Requirements for INDs and BA/BE Studies” (December 2012) and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” (January 2009); accordingly, FDA has withdrawn the 2012 and 2009 guidance documents.
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