Breakthrough therapy designation: From serious diseases to opioid crisis prevention

AdobeStock_424041822 (1) [Converted]

Source: Adobe Stock

Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...

 This is member-only content

To read this article, SIGN IN NOW if you are a TOPRA member.


Not a TOPRA member yet? Join our global community.

Five great reasons to become a TOPRA member:

  1. Great savings on our events and training.
  2. Be part of our dynamic international community.
  3. Contribute to the profession.
  4. Grow your skills and knowledge.
  5. Take your career to the next level.

Have you heard what you’re missing? Listen now to the RegRapPod podcast show, for free!