Module 5 Presentations

16/07/2024

FDA and Expedited Safety Reports – Dec 2012

• “Findings from animal studies, such as carcinogenicity, mutagenicity, teratogenicity, or reports of significant organ toxicity at or near the expected human exposure are examples of the types of findings that could suggest a significant risk.” • “Before reporting a finding to FDA, the sponsor should use judgment to decide whether the finding suggests a significant risk in humans or is too preliminary to interpret without replication or further investigation. “ • To be reported “as soon as possible, but no later than 15 calendar days after the sponsor receives the safety information and determines that the information qualifies for reporting.”

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

45

Conclusion - The Aims of Safety Assessment

Clinical Development

One dose

Lifetime use

Reproduction

Chronic Effects

Acute Responses

Development

Genetic damage

Carcinogenicity

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

46

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