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Chemical Approval Process  Form

Chemical Approval Process Form

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Safe and effective drugs are essential to caring for your patients. So here are 5 things to know about how FDA approves a drug for use. It starts when a drug is investigated and screened. Generally, New drugs are tested on animals before people. Additionally, in some cases, multiple species are used to gather information on the safety of the compound being investigated. The drug sponsor submits an investigational new drug application (IND) to the FDA based on the results of the initial testing. The application is required to include the drug’s composition, as well as the details of its manufacturing. The IND presents a plan for testing the drug on humans. The FDA reviews the plan to determine if the proposed clinical trials will put human subjects at unreasonable and significant risk of illness or injury. Generally, there are three phases to a clinical trial in humans. Phase one emphasizes safety and typically includes 20-80 healthy volunteers. Phase 2 emphasizes effectiveness and ty

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