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Posted 25 June 2021 | By Jeff Craven 

FDA releases new draft guidance on sponsor role for safety reporting requirements

2961 The US Food and Drug Administration (FDA) has released a new draft guidance for sponsors on safety reporting requirements and assessments for investigational new drug application (IND) and bioavailability/bioequivalence (BA/BE) studies.
In a notice announcing the availability of the draft guidance, FDA said this latest version iterates on the “Safety Assessment for IND Safety Reporting” draft guidance released in 2015, and “provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices.”
Comments to the 2015 draft guidance by industry included concerns about how to conduct safety assessments for INDs in light of FDA’s call for sponsors to create safety assessment committees (SACs). One recommendation in the 2015 draft guidance that drew particular attention from industry was a provision for sponsors to report potential serious risks within 15 calendar days if an SAC identified information that would require IND safety reporting.
The Biotechnology Innovation Organization (BIO) expressed a desire for more flexibility within the SAC recommendation, particularly for small and mid-sized companies, to avoid operational challenges. “[I]t is unclear whether the presence of an SAC will result in earlier detection of important safety information. As such, we believe it would be more beneficial and appropriate if this draft guidance focused on safety surveillance plans, which in some cases may include an SAC as part of the plan,” BIO said.
GSK and Teva indicated the role of the SAC may in some cases overlap with existing safety reviews. Teva encouraged FDA to conduct a pilot program to establish the feasibility of implementing SACs, while GSK asked the agency to “allow for a flexible approach to meet the regulatory requirements, the details of which would be clearly articulated in the Safety Surveillance Plan (SSP).” (RELATED: Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs, Regulatory Focus 17 February 2016)
FDA noted the new draft guidance addresses feedback received about the 2015 draft guidance while also incorporating “largely unchanged” elements of the “Safety Reporting Requirements for INDs and BA/BE Studies” final guidance for industry and investigators published in 2012. (RELATED: FDA Offers Draft Guidance on IND Safety Reporting, Regulatory Focus 16 December 2015)
Changes to the new draft guidance include revised recommendations about planned unblinding of safety data, flexibility in determining the entity reviewing IND safety information, “clarification regarding the scope and methodology for aggregate analyses” and “clarification regarding the plan for safety surveillance, including what elements should be included in the plan.”
Concerning 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 agency said.
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.
Although the agency is withdrawing the 2015 guidance at the same time it is publishing the current guidance, FDA noted this guidance does not include information pertaining to investigator responsibilities, and a separate guidance for investigators is planned. The final guidance document published in 2012 on industry and investigator responsibilities for safety reporting concerning human drug and biological products under IND “remains in effect and represents FDA’s current thinking” until the new guidance is finalized, the agency said.
Sponsor Responsibilities— Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry


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