Pfizer Indiplon “Refuse To File” For eNDA May Stem From Shift In FDA Oversight
Executive Summary
FDA's shift of responsibilities for Pfizer/Neurocrine's insomnia drug indiplon between review divisions may have led to the agency's delay in accepting the NDA
You may also be interested in...
Chelsea Vows To Resolve Latest Regulatory Woes With Northera Quickly
Technical deficiencies foil the resubmission of Chelsea Therapeutics’ Northera. The company thinks it can resolve the problems quickly and some analysts expect a relatively short delay of one or two months to the user fee date.
Complete Submissions Are Key To Good Review Management Principles – FDA
As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process
Complete Submissions Are Key To Good Review Management Principles – FDA
As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process