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The FDA Roundtable Part II: REMS, Outcomes Studies and Drug Withdrawals

 
• By Ramsey Baghdadi

In Part II of The RPM Report’s roundtable discussion with three top FDA officials, the importance and implementation of FDA’s new REMS authorities, drug withdrawal precedents and the agency’s view of outcomes studies are the focus of the discussion.

How have sponsors been approaching negotiations over drug labeling and risk evaluation and mitigation strategies (REMS)? In what cases does the agency decide to ask for a REMS? What does FDA think of the new cases of a serious side effect associated with Biogen Idec’s multiple sclerosis drug natalizumab (Tysabri)?

Office of New Drugs director John Jenkins, Office of Surveillance and Epidemiology director Gerald Dal Pan and Office of Medical...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
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The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
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Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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

 
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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.

US FDA May Consolidate Support Services After Extensive Cuts

 
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Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.