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FDA Commissioner Candidate Gulfo Hates Breakthrough, Wants To Reevaluate User Fees

 
• By Derrick Gingery

In an interview, Joseph Gulfo, former medtech industry CEO and vocal FDA critic, outlines his worldview and interest in pushing aggressively against increasing the FDA ‘body of law.’

FDA entrance sign 2016

FDA Commissioner candidate Joseph Gulfo may have endeared himself to many agency reviewers with his call to end the breakthrough therapies program. But then again, his ideas for a multi-tiered approval system based on various types of evidence also could cause more concern.

Gulfo, a senior fellow at the Progressive Policy Institute and executive director and professor of health sciences at the Fairleigh Dickinson University Lewis Center for Healthcare Innovation and

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Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
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UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

More from Pathways & Standards

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

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.

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.