Safety Evaluation: International Regulations for Drug and Medical Device Approval

Become an expert on the international drug laws and regulations that pertain to safety and discover how safety procedures can be successfully implemented. Safety Evaluation: International Regulations for Drug and Medical Device Approval describes the development process for products in various markets and outlines those aspects of drug and device regulation related to evaluating safety.

Reviewing the major regulatory bodies responsible for the approval of new products, particularly in the US, Europe, and Japan, this source provides a clear understanding of regulation requirements.

This guide:

• synthesizes disparate international drug regulations
• covers both drugs and medical devices
• provides clear, how-to advice on meeting safety testing and evaluation regulations
• includes a glossary of acronyms and a directory of regulatory