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The U.S. Food and Drug Administration has issued the draft guidance for industry, “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE).”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and investigators, “Safety Reporting Requirements for INDs and BA/BE Studies” (December 2012) with content from the draft guidance for industry, “Safety Assessment for IND Safety Reporting” (December 2015).
The new draft guidance has removed the investigator provisions of the 2012 guidance for stakeholders’ convenience. FDA plans to publish a separate draft guidance on investigator responsibilities for safety reporting requirements.
The new draft guidance aims to help sponsors comply with expedited safety reporting requirements for human drug and biological products that are being investigated under an IND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.
Timely reporting of meaningful safety information strives to protect human patients participating in research studies. Safety information lets sponsors and FDA consider whether any modifications in study design and/or conduct should be made. It also allows investigators to implement changes when necessary to reduce risks involved in research participation.
The 2021 guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that sponsors raised. It also provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data.
This guidance includes revised recommendations on some topics described in the 2015 draft guidance. Content from the 2012 final guidance remains largely unchanged in this new guidance, except that the investigator responsibilities section has been removed. When finalized, this guidance will supersede the 2012 final guidance. Until that time, the 2012 final guidance represents FDA’s current thinking about safety reporting requirements for INDs and BA/BE studies.
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