1. Pink Sheet

US FDA’s Reclassification Of Certain Drugs As Devices May Be 'Seismic Event' For Some

 
• By Brenda Sandburg

Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.

Seismic wave
Court ruling on drug-device classification has potential to be seismic event • Source: Alamy

The US Food and Drug Administration’s plan to transition certain products regulated as drugs to device status could have significant repercussions for the pharmaceutical industry. While the agency is focusing on whether imaging agents meet the device definition, it is also reexamining other product categories as well. Sponsors have already received complete response letters and notices of deficiencies in their applications as a result of the reclassification.

In August, the agency announced in a Federal Register notice that it would be publishing a list of approved drug...

More from Pink Sheet Perspectives

More from Pink Sheet

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges