Dueling headlines from the Pink Sheet -- and both true:
“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.
Egrifta Approval Suggests Evolution In FDA Thinking On Role Of REMS
FDA’s decision not to require a Risk Evaluation and Mitigation Strategy for Theratechnologies’ HIV lipodystrophy drug Egrifta (tesamorelin) suggests the agency is becoming more circumspect in how it applies its drug safety powers under the FDA Amendments Act more than two-and-a-half years after they took effect.
Wither predictability?
