Thanks Sequester: FDA’s Human Drug Review Costs Decrease To Pre-FY 2011 Level
The agency says human drug review costs were less than $1 billion in fiscal year 2013, the first time that’s happened since FY 2010.
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“Given the limited availability of investment capital for medical product development, early clarification of regulatory requirements is critical,” FDA says.
Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.
Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too
Analysis of meetings in FDA’s public calendar indicates Commissioner Hamburg, other senior leaders continue to attend meetings throughout the U.S. and overseas; stakeholders worry sequester-induced travel cuts prevent rank-and-file scientists from attending helpful events.