
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices 1st Edition PDF Free Download
The book Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices is written by John J. Tobin, and Gary Walsh. Medicines and medical devices are among the most tightly regulated products in the developed world. This chapter introduces you to the basic principles and concepts behind regulations so you can fully appreciate the importance of compliance. The chapter then analyzes the general legislative framework used to create regulations and identifies the core legal texts used to regulate such products in the European Union (EU) and the United States of America (USA). Finally, the chapter examines the legal definitions of drugs and medical devices, which are central to determining the scope of regulations.
In a modern constitutional democracy, laws are created thro...