FDA User Fee System Doubted By Consumers; Legislative Change Is Unlikely
A recent poll evaluating consumer confidence in FDA suggests a lack of confidence in the agency's user fee system
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FDA will use collaborative agreements to reduce its labor costs in field operations, Deputy Commissioner for Policy Amit Sachdev said during an AEI/Brookings Institute Joint Center for Regulatory Studies conference Feb. 16
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FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials