FDA Gets Broad Exemptions From Federal Hiring Freeze In HHS Memo

Advisory committees will need to be 'legally mandated' in order add special government employees, but many positions at FDA appear as though they can be filled, internal memo suggests – though how specific those exemptions are is unclear.

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President Trump's 90-day federal hiring freeze appears to offer some broad exemptions for key positions at the US FDA.

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 

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US FDA Advisory Committee Meetings In Jeopardy After Layoffs, But Some Employees Called Back

 
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Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 

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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.