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In this article we summarize the most useful portions and identify potentially unnecessary details in these mock submissions and provide insight as to how CDER reviewers assess submissions of pharmacogenomics data. Fariba Ghodsian, analyst with Roth Capital Partners LLCs in Los Angeles, said investors perceived the FDA's move as positive because CDER ``knows more about the whole approval process. CDER classifies NDAs according to the type of drug and its intended uses. |
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