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Tuesday, 06/05/2018 5:45:43 PM

Tuesday, June 05, 2018 5:45:43 PM

Post# of 463840
“To promote the most promising opportunities and address the
corresponding intricacy of these new endeavors, the FDA has introduced
many fundamental advances in how it evaluates drugs for safety and
effectiveness, as well as the manner in which clinical trials are
guided. These include adaptive approaches to clinical development such
as the introduction of seamless trial designs or master protocols or
tissue agnostic product approvals. Each allow us to better marry the
scientific prospect more closely to the approaches that can best
unlock these opportunities.

https://www.news-journal.com/ap/national/statement-from-fda-commissioner-scott-gottlieb-m-d-on-proposed/article_3c3cd278-f6cb-5ad2-b045-9b44a2f32b26.html
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