FDA and Global Genes Co-Sponsor Rare Disease Workshop

CDER Rare Disease Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development

Global Genes and the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) co-sponsored a public workshop on how to effectively communicate with the FDA on October 30, 2017.  

  • Who is the FDA and what do they do?
  • How is the FDA involved in patient engagement and rare disease?
  • What types of patient engagement are possible by interacting with the CDER and the FDA?
  • Case Studies: Patient groups that engaged with the FDA’s CDER
  • How can you develop an effective engagement strategy with the CDER at FDA?