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66 FR 65978 Draft Guidance for Industry Exemptions Gpo  Form

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[Music] the regulatory milestones during drug development are generally used to divide the drug development process into stages from preclinical to clinical phases 1 through three and finally approval as a result there are several regulatory milestones along the drug development timeline however two important written documents are required from a pharmaceutical firm seeking regulatory approval from the united states fda the first is an investigational new drug ind application and the second is a new drug application nda or biologic license application bla the imd is required for approval to begin human clinical trials for a new drug clinical trials for new drugs are conducted as part of the development process prior to marketing following the success of clinical trials an nda or bla is filed for approval and marketing in some cases a drug that has not yet been approved for marketing can be made available to patients suffering from a life-threatening disease who have no other treatment

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