FDA Emphasizing Written Communication With Sponsors On Pending NDAs
Executive Summary
FDA will emphasize official written action letters in its internal policy on communication with sponsors drafted in response to the Congressional investigation of the Erbitux review, Acting Commissioner Crawford said Oct. 10
You may also be interested in...
Good Review Management Guidance To Be Tested By “Root Causes” Analysis
FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005
Good Review Management Guidance To Be Tested By “Root Causes” Analysis
FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005
PhRMA Feels Deadline Pressure, Reminds FDA Of Flexibility In PDUFA Goals
The Pharmaceutical Research & Manufacturers of America is suggesting that FDA can miss its user fee deadline for a product if prolonging the review would lead to swifter approval than entering a second cycle