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PDUFA Extension Adds More than Funding

Executive Summary

The expiring Prescription Drug User Fee Act (PDUFA) has been reauthorized and expanded. For the first time, the bill provides a mechanism for risk management planning. The new PDUFA also requires FDA to turn to independent consultants to help resolve disputes over Phase III trial design. At a time when managerial issues at the FDA seem to have raised the level of uncertainty, the new PDUFA rules could prove a welcome measure of predictability.

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At the same time that FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's also thinking of taking a tougher position with existing drugs.

Pharmacogenomic Data and Labeling: A Less-Safe Harbor for Existing Drugs?

At the same time that FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's also thinking of taking a tougher position with existing drugs.

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