The U.S. Food and Drug Administration has issued the draft guidance for industry, Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE). This guidance merges content from the final guidance for industry and investigators, “Safety Reporting Requirements for INDs and BA/BE Studies” (December 2012) with content from the draft guidance for industry, “Safety Assessment for IND Safety Reporting” (December 2015).
The new draft guidance aims to help sponsors comply with expedited safety reporting requirements for human drug and biological products that are being investigated under an IND application, or as part of a BA or BE study that is exempt from IND requirements. This guidance provides recommendations about a systematic approach for safety reporting, including recommendations for sharing safety information among entities involved in drug development.
Download the guidance here.