ANDA Complete Responses Spike In FY 2018, But Why?
Executive Summary
In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.
Topics
- Subjects
- Generic Drugs
- Review Pathway
- Regulation
- FDA
- Industries
- BioPharmaceutical
- Regions
- North America
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PS122349
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