FDA Needs External Board Of Directors, Former Commish von Eschenbach Says
Cleveland Clinic’s Steve Nissen calls for new marketing exclusivity, while FDA’s Hamburg cites agency’s openness to biomarkers, innovative clinical trial designs in forum on how to enhance the agency’s performance.
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CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.
The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.