september, 2019
20sep12:00 pm1:00 pmLeveraging FDA’s Expedited Programs to Accelerate Product DevelopmentWebinar
Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years. Responding to this interest, the
more
Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years.
This webcast will highlight the requirements, benefits, and procedures for Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. We will also discuss two newer programs, Regenerative Medicine Advanced Therapy (FDA guidance, Feb 2019) and Qualified Infectious Disease Program (FDA guidance, Jan 2018). This webcast will also describe the importance of establishing a therapeutic area as a serious condition with unmet medical need for each of these programs and provide examples for this.
Webinar Overview:
Title: Leveraging FDA’s Expedited Programs to Accelerate Product Development
Date: Friday, September 20, 2019
Time: 12:00-1:00 M Eastern Daylight Time
Register for this Complimentary Webinar Now (you will be brought to the Xtalks website for registration)
Time
(Friday) 12:00 pm - 1:00 pm