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
Charlene Revel, PharmD, MSc.
Senior Regulatory Scientist, Drugs and Biologics
Charlene has great experience in the implementation of global regulatory and scientific strategies as well as submissions for the development and marketing of biologics products, drugs and medical devices.
Michael Day, PhD
Senior Director, Regulatory Science
Mike has over 20 years of experience in the pharma biotech industry and consulting services, having worked on the review, preparation of numerous regulatory documents and submissions, including those through accelerated programs.
Senior Director, Regulatory Science, Drugs & Biologics
Mark has a proven history of building and maintaining good relationships with FDA personnel to facilitate development and commercialization of new products (Orphan Products, PDUFA meetings, CBER and CDER Review Divisions including OTAT). He has managed post-approval submissions of all types, including advertising and promotional materials, drug product listings, CMC and labeling supplements.