Will Breakthrough Therapies Face Reimbursement Challenges?
After an Aetna official suggests there may be reimbursement uncertainty for products developed under the new expedited regulatory pathway, CDER Director Woodcock defends FDA’s review process and says such drugs are expected to be robustly more effective than existing treatments.
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Device center officials cite a host of formal and informal actions available under existing legislative authority to ensure that development and review of companion diagnostics do not hinder the ability of FDA-designated breakthrough therapies from coming to market.
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