Earlier this summer, the United States Food and Drug Administration (FDA) released updated draft guidance for sponsors on safety reporting requirements and safety assessments for investigational new drug application (IND) and bioavailability/bioequivalence (BA/BE) studies.
This new draft guidance merges content from the final guidance for industry and investigators in December 2012 (Safety Reporting Requirements for INDs and BA/BE Studies) and the draft guidance for industry in 2015 (Safety Assessment for IND Safety Reporting). The incorporated content remains largely unchanged from the prior guidance.
This guidance includes revised recommendations initially outlined in the 2015 draft guidance on: (1) planned unblinding of safety data and implications for trial integrity; (2) increased flexibility regarding the party reviewing aggregate safety information for IND safety reporting purposes; (3) clarification regarding the scope and methodology of aggregate analyses; and (4) clarification regarding the plan for safety surveillance, including what elements should be included in the plan. The 2015 draft guidance has been withdrawn upon the publication of this guidance and once this guidance is finalized, the 2012 final guidance will be superseded by the new final guidance.
Changes in the Draft Guidance
With respect to the review of IND safety information, FDA said a sponsor may now “choose to designate an entity (an individual or group of individuals) to review the accumulating safety information in a drug development program and to make a recommendation to the sponsor regarding whether the safety information must be reported.” In addition, sponsors “have flexibility in determining which entity or entities should perform this function.”
The guidance also “provides sponsors and sponsor-investigators recommendations regarding expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subject of BA and BE studies that are exempt from the IND requirements,” FDA wrote in the notice.
More Guidance is Expected
While this draft guidance does not include content on investigator reporting like the 2012 final guidance did, FDA plans to publish a separate draft guidance for clinical investigators on investigators’ responsibilities for safety reporting for human drug and biological products that are being investigated under an IND. Until that draft guidance is finalized, the 2012 final guidance continues to represent FDA’s current thinking about investigators’ responsibilities for safety reporting for INDs and BA/BE studies.
Comments
Interested parties can submit electronic or written comments on the draft guidance by September 27, 2021.