Toxicology Initiative From US FDA Aims To Replace Animal Safety Models, But Slowly
Predictive Toxicology Roadmap will help make drug development more efficient by promoting new technologies for safety testing, Commissioner Gottlieb says.
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OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.
To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.
Outgoing Biotechnology Innovation Organization CEO suggests consideration of price inflation caps instead of 'big discounts' in Medicare Part D and says that industry should fund a cap on beneficiary out-of-pocket costs in the program.