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PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up

 
• By Derrick Gingery

FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.

FDA efforts to systematize patient experience data appear likely to be at least a discussion topic for PDUFA VI negotiations and potentially an area for continued fee support.

Agency officials want to figure pragmatic and appropriate methods to incorporate patient experience

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More from United States

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from North America

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.