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CFDA to Begin Conducting Surprise Inspections
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China Requiring Sponsors to Show GCP Compliance
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U.S. House Passes FDA Overhaul Bill, Senate Version in the Works
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Electronic Document Management Systems for Drugmakers
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Electronic Batch Recording and Batch Release for Drugmakers
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FDA Gets To-Do List in House, Senate Appropriations Bills
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Fiscal 2016 User Fees Going Up for Generics, Biosimilars
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Drugmakers Raise Concerns About CMC Draft Guidance
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Another Generics Maker Gets FDA Warning for Skipping GDUFA Fees
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Biosimilar Interchangeability Laws Mostly Mirror BIO Guidelines
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FDA Announces Quality Metrics Details; Drugmakers to Focus on 10 Data Points
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Will You Be Ready for Your Next GMP Inspection?
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