The EU Innovative Health Initiative (IHI) has called for research to be undertaken in the EU to explore how regulatory sandboxes can be developed for health care innovations and integrated into regulation and policy.
EU Offers Research Funding For Regulatory Sandboxes And Novel Endpoint Projects
Europe’s Innovative Health Initiative, a public-private funding partnership, has put out a call for a research project that could help analyze the use of regulatory sandboxes in health care innovation in addition to three others.

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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.