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MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES UNITED STATES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Date: Subject: January 30, 2006, Clinical
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Clinical review of new is a process that aims to evaluate the safety and efficacy of a new medical product or treatment before it can be approved for use.
Manufacturers or sponsors of the new medical product or treatment are required to file the clinical review of new.
The clinical review of new can be filled out by providing detailed information about the medical product or treatment, including its composition, manufacturing process, and results from clinical trials or studies.
The purpose of the clinical review of new is to ensure that the new medical product or treatment meets the necessary safety and efficacy standards before it can be approved for use.
The clinical review of new must include information on the composition of the medical product or treatment, its manufacturing process, and the results from relevant clinical trials or studies.
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