Chart: How Should Advisory Committees Handle REMS? Or Should They At All?
How Should Advisory Committees Handle REMS? Or Should They At All?
You may also be interested in...
Sponsors facing an FDA advisory committee should be prepared to discuss Risk Evaluation and Mitigation Strategies, even if FDA tells a company that a REMS need only have minimal elements or is not necessary, to avoid a negative vote, industry experts say.
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
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011