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Regulatory Focus™ > News Articles > Balancing Regulatory Approval With Reimbursement and Patient Access in the Era of Comparative Effec

Balancing Regulatory Approval With Reimbursement and Patient Access in the Era of Comparative Effectiveness Research

Posted 01 October 2010

Significant changes have occurred throughout the global biopharmaceutical and medical device markets. The new reality is that regulatory approval in many major markets no longer equates to commercial success and optimal patient access. Manufacturers are required to invest more resources in the product development process to be successful in many global markets. Many countries require manufacturers to obtain reimbursement approval before being permitted to enter the market. This approval depends upon the ability to demonstrate product value. Therefore, manufacturers are required to invest more resources in the product development process to succeed in penetrating target markets.

 

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