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Preclinical Level 2 Final Evaluation Procedures Please note: Google Links should not be shared amongst different preclinical levels. They are all unique to the preclinical level indicated. Step 1:
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Preclinical level 2 final is a report that summarizes the results of preclinical studies conducted before human testing of a new drug or medical device.
The sponsor or manufacturer of the drug or medical device is required to file the preclinical level 2 final.
To fill out the preclinical level 2 final, the sponsor or manufacturer must include detailed information about the preclinical studies conducted, including methodology, results, and any adverse effects observed.
The purpose of the preclinical level 2 final is to provide regulators with important safety and efficacy data from preclinical studies before human testing begins.
The preclinical level 2 final must include information on the study design, methodology, results, conclusions, and any adverse effects observed during the preclinical studies.
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