Description of Collaborative Activity: |
A group of NIH's Therapeutics for Rare and Neglected Diseases (TRND) staff and FDA staff from the Center for Drug Evaluation and Research (CDER) meet on a semi-monthly basis to discuss projects for the TRND program. The purpose of this working group is to discuss the scientific progress on each project toward the eventual goal of an Investigational New Drug Application for each project. Results of experiments are discussed, and TRND staff takes the feedback of FDA/CDER staff into consideration when developing future project plans. |