FDA Credibility Becomes A Central Theme For Industry In 2005
This article was originally published in The Tan Sheet
Executive Summary
FDA's credibility crisis is likely to shadow much of its agenda for the coming year and could result in significant changes at the agency
You may also be interested in...
US Medicare Plans 'Can' Cover Wegovy, CMS Says, But Will They?
Medicare is making clear that Part D ‘can’ cover GLP-1 inhibitors that are approved for cardiovascular indications – but in language that seems to leave plans considerable discretion for now. The formulary review process for 2025 may be a more important milestone for changes.
An Artificial Intelligence Milestone For US FDA
A project to validate a depression severity measurement tool that employs artificial intelligence for use in drug trials is moving forward at FDA. The milestone is a sign of things to come – and of the incremental process for AI adoption by the regulator.
Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For ‘Novel’
In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.