A policy update removes a longstanding barrier for medical device sponsors and signals a broader shift that could eventually reshape how drug and biologic developers approach evidence generation.
Disruptions to key Middle East logistics corridors are rippling through pharmaceutical supply chains, raising costs and testing resilience, but not yet triggering shortages.
Industry leaders at the Advanced Therapies conference outline how early collaboration, funding, and culture shape whether breakthroughs reach patients.
Ireland’s model for advanced therapy manufacturing integrates academic research, workforce development, and regulatory bodies to streamline the production of complex biologics.
Automation, digital manufacturing, and regulatory reform are reshaping how the UK competes in cell and gene therapy as the field moves toward routine delivery.
While faster reviews could bring life-saving treatments to patients sooner, compressed timelines could also limit regulatory scrutiny and strain FDA resources.
The FDA’s National Priority Voucher program aims to cut standard review times from potentially years to months, raising questions about safety, access, and public health impact.