CER, Reimbursement Issues Drawing More Attention From Reg Professionals
Executive Summary
Pharmaceutical manufacturers’ efforts to address comparative effectiveness and reimbursement issues earlier in their regulatory strategies are borne out in a study showing growing involvement by regulatory professionals in these areas.
You may also be interested in...
CMS/FDA Parallel Review: Agencies Weighing Process For Planning Trials That Satisfy Both
CMS and FDA are considering a voluntary process that would help drug, biologic and medical device sponsors design clinical trials that would ultimately support both FDA approval and CMS national coverage decisions for Medicare reimbursement.
CER's Place In Drug Development Is A Work In Progress, FDA Says
FDA has a lot of work to do before it can determine how comparative effectiveness research might play into its evaluation of new drug approvals or labeling changes, Chief Scientist and Acting Deputy Commissioner for Science and Public Health Jesse Goodman told a conference sponsored by the Friends of Cancer Research June 18
Venture Capitalists Have A Growing Interest In Comparative Effectiveness
Venture capitalists are taking a growing interest in the impact of comparative effectiveness research on future drug products and how results might affect products' ability to gain coverage by third-party payers