'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...
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Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US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.
Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement
Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: