FDA, CMS To Standardize Regulatory Analytical Tools
FDA, CMS and other agencies within the Department of Health and Human Services will combine forces to improve and standardize analytical tools used in regulatory decision-making.
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BALTIMORE – Decisions by the soon-to-be-created Independent Payment Advisory Board could make CMS participation in parallel review of drugs with FDA much more meaningful than it would otherwise be, assuming the health care reform law remains intact, former CMS and FDA official Scott Gottlieb said.
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.