Responding to this interest, the United States government has passed a number of laws intended to encourage the development of products for these indications, including the Prescription Drug User Fee Act of 1992 (PDUFA), the Food and Drug Administration Modernization Act of  1997 (FDAMA), and most recently, the 21^st Century Cures Act of 2016.  Responding to these directives from Congress, FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies.

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.

 

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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)