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Workgroup Report Review of Genomics Data Based on Experience with Mock Submissions-View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee.pdf
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26
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For pharmaceutical companies, quality control is a top priority, and with organizations like CDER1 (Center for Drug Evaluation and Research) “dropping by” for inspections, the quality control process can also be stressful. You might wonder for instance why some CDER inspections are announced and some conducted by surprise. This article, based on an interview conducted for MasterControl, will offer information that gives pharma companies the information that they need to understand the “surprise or no surprise” question.
29
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【doc】 借鉴美国CDER经验完善我国药品再评价体系.doc
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CDER加快药品审评途径
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