Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017-2019.

Atasi PoddarMiranda RaggioJohn Concato

Published in: Therapeutic innovation & regulatory science (2023)

This analysis describes CDER's decision-making process related to review of requests for breakthrough therapy designations and enhances public awareness regarding efforts to expedite drug development.

Keyphrases

decision making
healthcare
palliative care
mental health
emergency department
stem cells
quality improvement
bone marrow