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The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
FDA has published draft guidance providing an approach for investigational new drug application (IND) safety reporting for drugs and biologics developed under an IND, as well as an overview of safety reporting requirements. The draft guidance is a follow-on to Safety Reporting Requirements for INDs and BA/BE Studies.
The guidance, which is applicable to sponsors managing a drug-development program, offers recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations at § 312.32 (21 Code of Federal Regulations 312.32). Specifically, the guidance recommends “the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned un-blinding of safety data, reporting thresholds for IND safety reporting, and the development of a safety surveillance plan.”