Regulatory Fitness in Rare Disease Clinical Trials Workshop - Day 1

On May 16 and 17, 2022, the National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) will host a jointly sponsored virtual workshop to explore Regulatory Fitness in Rare Disease Clinical Trials. Topics will include: adequate and well-controlled trials, core principles for clinical trials, nuts and bolts of investigational new drug (IND) applications, additional pathways to interact with FDA, and case studies.

• FDA, Center for Drug Evaluation and Research (CDER)
• NIH, National Center for Advancing Translational Sciences (NCATS)

• Virtual Workshop
• FDA Drug Development Resources for the Rare Disease Community and More
• CDER's ARC Program