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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

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.