ASA finds device marketer BioLife Solutions could not rely on a disclaimer and use of the word “therapy” instead of “treatment” to offset the message its Airnergy device treats a medical condition. ASA advices not to make COPD treatment claims unless a product is properly certified.

ASA finds device marketer BioLife Solutions could not rely on a disclaimer and use of the word “therapy” instead of “treatment” to offset the message its Airnergy device treats a medical condition. ASA advices not to make COPD treatment claims unless a product is properly certified.

House subcommittee approves DXM Abuse bill; UK ire for US firm’s patch claims; Innophos VP hire; and more news in brief.

The Orthopaedic and Rehabilitation Advisory Panel recommended FDA require a randomized, sham-control study design with a well-defined patient population to prove safety and effectiveness for the devices. The agency is currently considering whether to retain the preamendments device category in class III or downclassify to class II.