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Take Care In Promoting Lab-Developed Genetic Tests Or Risk US FDA, FTC Ire

 
• By Sue Darcey

Device-practice attorneys provide tips and precautions for laboratories advertising and promoting non-cleared or unapproved molecular-based diagnostics, and avoiding enforcement.

Laboratories that develop genetic tests should be able to promote or advertise their services, regulatory attorneys say, but they risk enforcement actions from US FDA and the Federal Trade Commission if they don't take special precautions with their claims.

Device attorneys offered tips on strategies for makers of laboratory-developed tests and direct-to-consumer genetic assays to avoid enforcement at the recent Food, Drug and Law

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Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.