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regulatory

This page shows the latest regulatory news and features for those working in and with pharma, biotech and healthcare.

Transforming access in rare diseases

Transforming access in rare diseases

A quiet revolution is underway that could transform access to medicines in rare diseases, according to Duchenne UK, the charity at the heart of a new project to streamline evidence-gathering in HTA

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  • Brexit Means Brexit Brexit Means Brexit

    strong overtones of working together) where products only need to undergo one series of approvals, in one country, to show that they meet the required regulatory standards. ... The Prime Minister specifically cited the importance of regulatory alignment

  • A new era of smart pharma A new era of smart pharma

    Clearly protocol endpoints and regulatory expectations must be addressed in any pre-authorisation trials.

  • Health on instalment Health on instalment

    The study concedes any such solution would require unprecedented regulatory approval and cooperation from the federal government, and in this respect the timing appears opportune.

  • The rise of real-world evidence The rise of real-world evidence

    The takeover was driven by a belief that “regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments, ”Daniel O’Day, ... While that seismic shift is unlikely to happen soon,

  • Digital health Digital health

    With digital health, the R&D path is completely different; the regulatory, content and reimbursement strategy are all very different.

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