FDA To Roll Out Biologics Policy In 2018, Focus User Fees On Innovation

By Beth Wang / December 7, 2017 at 8:47 PM
FDA plans to roll out a suite of new policies in early 2018 that FDA Commissioner Scott Gottlieb told stakeholders Tuesday (Dec. 5) will help make the biologics and biosimilars space more sustainable and a viable area of competition. Gottlieb also discussed other ways FDA could reshape regulatory policies, chiefly by taking a more general approach to user fees to focus more on innovation and drug development, and ensuring user fee resources are more equally distributed throughout the agency. During...


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