Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement
Executive Summary
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.
You may also be interested in...
Medicare New Technology Add-On Payment Awards For Hospital Drugs On The Rise
Eight inpatient prescription drugs are deemed eligible for supplemental payments in 2020, a big increase from years past, based on a review of US Medicare's new technology add-on payment approvals for prescription drugs since 2011.
Achaogen Questioning Whether Others Will Pursue LPAD Pathway After Zemdri Misses Out
Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected.
'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
