PDUFA's 'Real-World' Journey Expected To Be Slow Walk

Manufacturers are enthusiastic about the possibility of using real-world evidence to expand product indications. But even with new resource support, they know it's a long road to get there.

PDUFA VI letter

For drug makers excited about the prospects of using so-called real-world evidence to expand product indications or fulfill postmarketing requirements, the journey ahead is going to be a slow one.

More from Post-Marketing Regulation & Studies

More from Product Reviews