Recalibrating Regulatory Strategies to Leverage Evolving Accelerated Pathways in the US and EU

Recalibrating Regulatory Strategies to Leverage Evolving Accelerated Pathways in the US and EU

This white paper is part of DIA’s White Paper Library

As the push for faster, smarter approvals fathers speed in the US and EU, accelerated pathways (APs) for drug development are evolving. This shifting landscape presents companies with opportunities (streamlined development, more regulatory advice, faster times to market) and risks (smaller clinical data sets, rapidly changing science, reimbursement hurdles). It will require agility and flexibility to reap the benefits while avoiding the pitfalls.

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