Real-world data collected from a wide range of sources, such as wearable devices and public databases, can be used by pharmaceutical companies to boost their marketing authorization and health technology assessment applications, a regulatory policy expert from Sanofi says.
The European Commission has indicated a “strong intent” to take real-world evidence and “broader health care data” into greater consideration during regulatory and HTA decision-making in the future, according to Rebecca Lumsden, Sanofi’s head of regulatory science & policy, EU/AMEE regions.
During a presentation at the RAPS Euro Convergence meeting on 7 May, Lumsden outlined the potential for companies to use...
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Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
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New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
