Case Reports in Surgery and Invasive Procedures

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Case Reports in Surgery and Invasive Procedures 44 7897 074717

Cancer Drug Development

They also look for new ways to use drugs that are already available. To do this, it must go through a long development and approval process.  But the actual amount of time and money needed depends on the drug. When the results from preclinical and clinical studies suggest that a potential new drug is safe and effective, a company will submit a new drug application (NDA) to the FDA.6 This application includes all of the preclinical and clinical data for the new drug, as well as its proposed labeling, directions for use, patent information, safety updates, and potential for drug abuse or misuse. Once the FDA receives the application, it decides whether the application is complete or not. Incomplete applications are not filed and are not reviewed. Complete applications must be reviewed and a decision issued by the FDA within 6 to 10 months

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