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US FDA Could Be Mostly Spared From Trump's Regulation-Slashing Order

 
• By Derrick Gingery

Even though the executive order that requires regulatory offsets may only have limited application to the agency, industry experts warn that it still could prove to be unwieldly to implement.

US FDA may be able to hide from President Trump's executive order requiring cost offsets for new regulations, so long as it can avoid their classification as "significant." But even though its application to FDA may be limited, industry experts warn that the order still could prove extremely difficult and unwieldly to implement.

The order demands that two regulations be eliminated for every new one issued. It also requires regulations to be scored...

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• By Amanda Maxwell

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HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

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International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

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Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 
• By Amanda Maxwell

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

More from Policy & Regulation

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
• By Ashley Yeo

Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.