"Safety Evaluation: International Regulations for Drug and Medical Device Approval" analyzes the international drug laws and regulations that pertain to safety and prescribes how safety procedures can be implemented. This text describes the development process for products in various markets, outlining those aspects of drug and device regulation related to evaluating safety. Presenting a review of the major regulatory bodies responsible for approval of new products, particularly in the US, EU, and Japan, this source also provides a clear understanding of the regulation requirements and includes current synthesis of disparate regulations. Features:
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