If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by FDA that can accelerate your product development and the review of your BLA/NDA.
This webinar will provide you some background on each of the tools and how you can leverage them to your advantage. The tools include – Fast Track (FTD), Breakthrough Therapy Designation (BTD), Regenerative Medicine and Advanced Therapies (RMAT), accelerated approval and priority review.
Some key learning points:
- Understand various mechanisms created by FDA to speed the product development and the BLA/NDA review
- Comprehend the types of situation to which these tools are applicable
- Familiar with the differences in the requirements to obtain each tool