Gottlieb Defends Accelerated Approval, Scorns Access Limits By Payors
US FDA's accelerated approval pathway is more reliable and has better validated biomarkers than a decade ago, commissioner says, arguing coverage limits on AA products are not in the interest of public health.
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Lower Drug Costs Might End Perception US FDA Approval Standards Are Lower
CDER Director Woodcock says pricing and approval issues are becoming "conflated" but it is hard to change people's minds when they are "determinedly angry about something."
Outcomes-Based Contract By Harvard Pilgrim For Testing Could Be Model For Pharma
Prenatal testing services provider IIlumina commits to fund study on whether cost of expanding use of test is offset by reduction in spending on traditional screening practices.
Breakthrough Therapy: 'A Lower Bar Of Evidence'?
MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?