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Clinical trial sponsors eventually may get quicker approval of their investigators now that the FDA, the National Cancer Institute (NCI) and CRIX International Association have signed an agreement establishing a public-private partnership to develop the NCI’s Federal Investigator Registry of Biomedi...
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Clinical trial sponsors would be asked to submit annual development safety update reports (DSURs) under a guideline proposed by the FDA to match one issued previously by the International Conference on Harmonisation (ICH).
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