AMENDMENT This amendment provides clarification in regard to the difference between the Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) and BPCA Clinical Trials Network (CTN). Although the DCC will be collecting, managing, and forwarding all of the study data to FDA, CTN offerors must have an understanding and experience in conducting Phase 1-3 clinical studies. They will have to ensure that the study is conducted according to the FDA regulations, and the data is generated appropriately, so the DCC will get relevant to submit to FDA for labeling. Therefore, it is necessary that CTN offerors have actual experience conducting pediatric clinical trials that are performed in accordance with US and EU regulations. The CTN will conduct the pediatric clinical trials and collects data. The data is then transferred to the DCC. The DCC monitors the data. The cleaned data is analyzed by the CTN with the cooperation of the DCC statistician. The Clinical Study Report is then submitted by the DCC to FDA.

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