Case Study on FDA Clinical Hold for toxicological

FDA Clinical Hold Lifted with DDReg’s Toxicology Expertise

Customer Requirement A US-based biopharmaceutical company conducting early-phase clinical development encountered a regulatory hurdle when the US FDA placed a clinical hold on its Phase 2 study application for a higher dose. The hold was issued due to toxicological findings observed during preclinical studies. To move forward, the company required scientific rationale and justification to […]

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