Sj Pharma Consulting Blog SJ Pharma comments on FDA's New Guidance on Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Two months ago, the Food and Drug Administration (FDA) released the long-awaited sponsor responsibilities guidance, which clarified terms such as suspected adverse reaction, and describes best practices for safety reporting, safety assessments for IND, and bioavailability/bioequivalence studies. The guidance shares key information necessary for IND safety reporting practices, and recommendations relating to IND safety reporting provisions that require accurate assessments of aggregated data. This is one of the latest documents the FDA has released in regards to safety compliance, and will significantly impact many pharmaceutical companies and pharmacovigilance consultants. This 2021 guidance extrapolates on topics discussed in the final 2012 guidance for industry and investigators "Safety Reporting Requirements for INDs and BA/BE Studies" and from the now withdrawn 2015 draft guidance for industry "Safety Assessment for IND Safety Reporting". The recent guidance provides revised recommendations initially described in the 2015 draft guidance on a variety of topics including: Planned unblinding of safety data and implications for trial integrityIncreased flexibility regarding the party reviewing aggregate safety information for IND safety reporting purposesClarification regarding the scope and methodology of aggregate analysesClarification regarding the plan for safety surveillance, including what elements should be included in the planWithin the first section of the guidance, FDA provides updated definitions of terms often used within pharmacovigilance audits. The terms discussed in this latest 2021 guidance include "adverse event," "adverse reaction," "suspected adverse reaction," "unexpected," "serious," and "life-threatening."The most important impact for industry of this latest guidance is the fact that the unblinding of selected datasets for the purpose of aggregate analysis no longer needs to be done by the safety advisory committee (with the associated risk of unblinding for small pharma companies). Instead, an independent Data Monitoring Committee (iDMC) can be used for unblinding purposes.Contributions provided by:Cristina Damatarca MD1st degree connectionPresident, SafePharm LLC