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.
You may also be interested in...
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.
With draft guidance allowing for drugs that improve heart failure symptoms but do not improve – or may even decrease – survival, the legal community could help establish development metrics.