US FDA Searches For Consistency On Assessment Of Real-World Evidence
As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.
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Jacqueline Corrigan-Curay brings a broad array of policy experience, from trial design to real-world evidence to supply chain and post-market surveillance, to the CDER principal deputy director role, though US FDA is not yet able to articulate exactly what her promotion will entail.
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.