US FDA Wants To Help Sponsors Generate Evidence CMS Needs, But Won't Be An Intermediary
FDA-CMS communications are expected to evolve as both agencies look to improve their relationship.
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FDA Commissioner Robert Califf said pharma should not be the sole entity handling postmarket research.
Instead of asking why confirmatory trials take so long, the FDA commissioner suggests insurance companies ask what they can do to help answer those questions.
A single-arm trial using a biomarker and animal model could be enough for an accelerated approval, especially in a pediatric rare disease where randomization and placebo controls may not be feasible, the CBER director said.