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Chart: How Should Advisory Committees Handle REMS? Or Should They At All?

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How Should Advisory Committees Handle REMS? Or Should They At All?

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“Defensive REMS” May Be Needed To Appease Advisory Committees

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.

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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

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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

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