CDER Touts FY 2024 Drug Safety Activities
CDER acting director Jacqueline Corrigan-Curay says that in FY 2024, the Center “continued its robust efforts to ensure that safe and effective prescription and nonprescription medications are available to improve the health of people in the United States.” In the Center’s 10th yearly drug safety report, she particularly cites:
- initiatives to modernize and improve the New Drugs Regulatory Program to enhance safety assessments;
- publication of Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP Are Working Together, describing areas of focus for developing and using artificial intelligence across the medical product lifecycle;
- establishment of the CDER Quantitative Medicine Center of Excellence;
- establishment of the CDER Center for Clinical Trial Innovation;
- strategies to address the overdose crisis; and
- publication of two guidances on drug products that may contain benzene and nitrosamines.