Advisory Committee Discussions Will Be Key Tool In Developing REMS
Executive Summary
Drug sponsors need not fear an advisory committee discussion about how to ensure safe use of their products, William Pullman, Chief Development Officer at Dyax, told a Jan. 13 Windhover webinar on surviving an advisory committee
You may also be interested in...
Where FDA Is Paying The Most Attention: Drug Safety Advisory Committee Had The Most Meetings In 2010
FDA’s ongoing efforts to ramp up its focus on drug safety are being borne out at the advisory committee level, which saw a doubling in the number of meeting days for the Drug Safety and Risk Management Advisory Committee in 2010.
Where FDA Is Paying The Most Attention: Drug Safety Advisory Committee Had The Most Meetings In 2010
FDA’s ongoing efforts to ramp up its focus on drug safety are being borne out at the advisory committee level, which saw a doubling in the number of meeting days for the Drug Safety and Risk Management Advisory Committee in 2010.
Chart: How Should Advisory Committees Handle REMS? Or Should They At All?
How Should Advisory Committees Handle REMS? Or Should They At All?