FDA has issued a final guidance, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which introduces a comprehensive and […]
[9/18/2023] Today, CDER, along with FDA’s Center for Biologics Evaluation and Research and the Oncology Center of Excellence, issued the draft guidance Demonstrating Substantial Evidence of Effectiveness […]
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