Featured Products
Used to mark a product as featured on the site
UDI Direct Marking for FDA Compliance: Navigating New Rules
$197.00
Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance. In the FDAnewsBrief, UDI Direct Marking for FDA Compliance, Crowley lays out a path to compliance.
Read More
Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best
$397.00
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future.
Read More
Special Protocol Assessment: Winning FDA Support for Trial Design
$397.00
The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.
Read More
False Claims Act Liability: A Guide for Drug and Device Manufacturers
$397.00
The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen.
Read More
Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval
$397.00
Are you hoping for a one cycle approval of your ANDA? This report explains how to meet the challenges and avoid the pitfalls in pursuing first-cycle ANDA approval.
Read More
Pharma Strategies in Latin America: Keys to Success
$397.00
Forget India. Forget China. The best new opportunities for pharmaceutical development can be found in an entirely different region — Latin America.
Read More