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.