
FDA Releases IND Safety Assessment Guidance
The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
FDA has published
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.”
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