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US FDA And The Lonely Return To The Office

 
• By Derrick Gingery

Employees are beginning to work in the office again, but are not finding many colleagues while at the agency’s White Oak headquarters.

Hybrid work
Some in industry are adopting hybrid work models to allow for in-person collaboration, while still providing a flexible environment. • Source: Shutterstock

Like much of the world, the US Food and Drug Administration is beginning to let staff return to the office, but may be having trouble maximizing its potential benefits, such as interacting with colleagues face-to-face.

John Scott, director of the Division of Biostatistics in the Center for Biologics Evaluation and Research’s Office of Biostatistics and Pharmacovigilance, said 8 April during the Drug Information Association/FDA Biostatistics Industry and Regulator Forum that during

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Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

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Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.