'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined
Executive Summary
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.
You may also be interested in...
Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims
In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.
FDA Warns Over Denigrating Biosimilars
The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.
Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US
The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.