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Right-to-Try or Right to Ask? 

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

See the big picture when it comes to right-to-tryRight-to-Try has been in the news a lot recently, 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