Breakthrough Products Should Be Free Of PDUFA Constraints, Sponsors Say
The types of FDA/sponsor interactions and timelines for meetings should not be limited by the user fee measure, industry commenters say in response to FDA’s draft guidance on expedited pathways. Some patient advocacy groups urge FDA to reconsider plans for withdrawing breakthrough designation in certain situations.
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Emerging Sponsors And FDA: Will Better Communication Under PDUFA V Ease Inherent Tensions?
New communication mechanisms built into the Prescription Drug User Fee Act V agreement are unlikely to be the panacea for the regulatory, economic and public relations challenges created when a small company attempts to bring its first drug to market.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.
Intercept’s OCA In NASH: When Hitting Surrogate Endpoint Is Not Enough For Accelerated Approval
Although US FDA reaffirmed its support of surrogate endpoints described in a 2018 draft guidance on NASH fibrosis, advisory committee members questioned the link to clinical benefit and said obeticholic acid’s serious risks made it difficult to consider the effect on the surrogate in a vacuum.