CDER’s Restructuring will Likely Reduce FDA Transparency and Create Delays for Drug Importers
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June 13, 2011
Law & Regulatory
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Tags: "Benjamin England", cder, center for drug evaluation and research, compliance, division, drugs, FDA, field, import operations, ODSIR, office, office of compliance, officer, policies, recalls, super, transparency
FDA’s Center for Drug Evaluation and Research (“CDER”) is establishing a new office, which in part will focus on drug importations. This move highlights CDER’s increased involvement in determining the compliance of individual drug-shipments imported into the United States. Also, this new office may likely centralize admissibility decisions, leaving the FDA field offices (and importers) waiting for decisions on drug entries. These affects will cause drug-importers greater delays in importing their products … READ MORE
