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Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

 
• By Michael Cipriano

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 

Medical advice and medication guidance and prescription drugs health consultation as a giant pill shaped as a lighthouse beacon with 3D illustration elements.

US FDA Commissioner Scott Gottlieb renewed his pitch for the agency to adopt a new paradigm for reviewing future opioid applications on the heels of the controversial Dsuvia (sufentanil sublingual) approval during a Nov. 8 speech, although this time he likely has a new audience listening: the upcoming Democrat-controlled House of Representatives.

Speaking at a private National Comprehensive Cancer Network (NCCN)/American Society of Clinical Oncology (ASCO) workshop, Gottlieb reiterated his desire to...

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More from Elections

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By Jung Won Shin

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Korean Pharma Industry Proposes Policies As Election Nears

 
• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 
• By Alaric DeArment and Jessica Merrill

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

More from Legislation

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.