Join FDA and the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation (CERSI) for a one-day workshop on Clinical Trials: Assessing Safety and Efficacy for a Diverse Population. The workshop will address the significance of population diversity in evaluating medical products and the methodological challenges in subgroup analyses in evaluating medical products for diverse populations.
Wednesday, December 2, 20158:30 a.m. to 4:30 p.m.
Food and Drug Administration
The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA has a new web section Medical Product Development Tools at FDA that brings together the tools, methods, and models that FDA has created to advance the development of new medical products.
FDA has introduced a new learning tool, Drug Approval Case Studies, for patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes.
Read FDA’s first case study in this series Drug Approval: Bringing a New Drug to the Market to learn how to navigate the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA.
No hay comentarios:
Publicar un comentario