Regulatory and HTA scientific advice activities are crucial to SME drug development success
EuropaBio, the European Association for Bioindustries, and the Deerfield Institute have partnered to carry out a survey on the current state of regulatory and health technology assessment (HTA) advice with a special focus on small and medium sized enterprises (SMEs).
The findings suggest early regulatory scientific and HTA advice may help SMEs to better prepare and manage their clinical programs toward facilitating both regulatory approval and positive HTA recommendations, and therefore contribute to their increased competitiveness.
Main findings
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