Differences Between Strategic and Tactical Development of V - PowerPoint Presentation

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Uploaded On 2016-06-16

Differences Between Strategic and Tactical Development of V - PPT Presentation

Melanie Hartsough PhD Biologics Consulting Group Inc 1 CDER approximately 3600 FTEs in 2013 18 review divisionsdivided based on indication CDER average of 26 NMEs approved per year Due to volume of work try to standardize requirements ID: 364900

ovrr studies clinical cder studies ovrr cder clinical product safety toxicity proteins programs assays reviewers nonclinical based dose review

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