FDA/Duke-Margolis Center for Health Policy Public Meeting

“Framework for Regulatory Use of Real World Evidence” on September 13, 2017 in Washington DC (9-4 pm)

FDA and the Duke-Margolis Center For Health Policy will hold a public meeting in September to gather input on opportunities and challenges for using real-world evidence to support approval of a new indication and to help satisfy post-approval study requirements, according to an agency notice. The 21st Century Cures Act directs FDA to consult with stakeholders in crafting a framework for use of RWE. Topics for discussion at the September public meeting include: challenges related to RWD collection and quality, innovative methods for developing RWE from real-world data, and promising areas for RWE pilot demonstrations, according to the agency notice.

For those of you who are involved in wound care research—this meeting is one you will want to attend. You can attend in person or via webinar. Sign up for it by clicking:



News sourced from Wound Care Alliance.

By | 2017-08-10T15:40:16+00:00 August 5th, 2017|Oxygen Observer, Uncategorized|0 Comments

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