Module 5 Presentations

18/07/2024

IND Safety Reporting

FDA has adopted the Guidance for Industry entitled: Safety Reporting Requirements for INDs and BA/BE Studies This guidance is intended help sponsors and investigators comply with safety reporting and expedited safety reporting requirements. It defines the terms used for reporting and provides recommendations on when and how to submit a safety report.

The Organisation for Professionals in Regulatory Affairs

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IND Safety Reporting (cont’d.) IND application sponsors are required to notify FDA in a written safety report for: ● Any adverse experience associated with the use of the drug that is both serious and unexpected; or ● Any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, and carcinogenicity. 21 CFR 312.32(a) provides terms and definitions for the following: ● Adverse event ● Serious adverse evert ● Life-threatening adverse event

● Suspected adverse reaction ● Unexpected adverse event

The Organisation for Professionals in Regulatory Affairs

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