White paper

Understanding Right-to-Try and FDA’s Expanded Access

You may be familiar with Right-to-Try, but what does it actually mean for product sponsors? This white paper explores both Right-to-Try legislation and existing Expanded Access Programs, including:

  • Understanding sponsor responsibilities under these programs and when products may be eligible for these programs
  • Evaluating options such as treatment protocols, treatment INDs, and emergency use
  • Discussing development risks associated with participation in these programs