Contingency Planning: Guidance Doc Details Handling Clinical Trials During Emergencies

 
• By Elizabeth Orr

The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.

A compass with text and icons - Be Prepared
• Source: Shutterstock

It was almost four years ago that the COVID-19 pandemic turned the world upside down, presenting a major crisis for ongoing clinical trials. The US Food and Drug Administration wants to ensure that whatever the next crisis is and whenever it arises, sponsors will never again be caught flat-footed.

That’s the core message of a new 34-page guidance document, which was issued on 21 September and co-signed by...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

More from Policy & Regulation