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‘Wrong Move’: Gottlieb Blasts Azar’s Perceived Regulatory Power Play Over FDA; HHS On Defense

 
• By Shawn M. Schmitt

The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”

HHS Building_1200

The US Department of Health and Human Services – the overseer of the Food and Drug Administration, and 27 other agencies and offices – played defense Sunday night, pushing back on suggestions that HHS secretary Alex Azar’s recent move to exert control over regulations was a power play aimed at the FDA.

The New York Timesreported over the weekend that Azar sent a memo to top staff on 15 September explaining...

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UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

More from Policy & Regulation

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

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Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.