regulatory

Market Access

The MHRA, will be running five pilot dialogues as part of its first year exploring a real-world evidence scientific dialogue programme.

Market Access

AI technologies can enable companies to program, rather than write, submissions to health authorities.

News

The UK has revealed a new 'innovator passport' designed to accelerate the rollout of proven medtech in the NHS.

News

Reports suggest a new framework for medicine reviews and a push to reduce NHS reliance on overseas-trained staff will feature in the 10-year plan.

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There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

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The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as the agency's leadership in this area is sidelined.