FDA Has Key New Constituency for REMS: Advisory Committee Members

FDA’s advisory committee members seem to be adopting the new post-marketing REMS authority with more enthusiasm than FDA’s own staff. Many of the advisory committee members – especially people who have served on the Drug Safety & Risk Management Advisory Committee – are jumping at the middle ground solution (between approval and rejection) offered by REMS. The Avandia re-review on July 13-14 demonstrated the strong appeal of REMS in a tough regulatory situation.

By Cole Werble

Duke cognition researcher Ruth Day and Colorado School of Public Health epidemiologist Elaine Morrato are part of an important new...

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