April 27, 2021

The ups and downs of ICER’s accelerated approval process

By Jane Barlow

The FDA’s accelerated approval process drives tremendous upside benefits for manufactures and patients through delivery of therapeutic innovations earlier than would otherwise occur.

The downside is increased risk of therapy failure and unexpected adverse events born by the health system, payers and patients. ICER and experts at Memorial Sloan Kettering’s drug pricing lab review the process, challenges and potential reforms to the process.

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