FDA发布申办者IND及BA/BE研究的安全报告要求与安全评估指导文件2025年12月，FDA发布【Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies】，提供了IND及BA/BE研究的安全报告与安全评估要求。 Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and BA_BE Studies_发布页.pdf Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and BA_BE Studies Guidance for Industry.pdf
