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What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers are starting to cover software-based healthcare products just like they…
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Overview of EU Regulatory Landscape for Regenerative Medicines
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INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation…
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The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
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What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers…
publication
Driving the Healthcare Regulatory System Into the Future
This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA…
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TOPRA/RAPS Workshop on Alignment of Global Combination Products
The TOPRA/RAPS inter-regulatory and stakeholder two-day workshop held in June 2020 focused on global combination product regulations. The diverse panel…
