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:
- ISBN10 084933098X
- ISBN13 9780849330988
- Publish Date 31 December 2050
- Publish Status Withdrawn
- Publish Country US
- Publisher Taylor & Francis Inc
- Imprint CRC Press Inc
- Format Hardcover
- Pages 376
- Language English