From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.

This chapter contains the second part of book’s study on cloud computing contracts.

The chapter examines how general contract law, as defined in the chapter, will likely apply to the use of cloud computing services. This chapter focuses on terms that are often considered standard in cloud agreements. The analysis includes terms aimed at keeping information confidential, non-disclosure agreements, terms regarding liability, warranties, and other terms and conditions aimed at regulating or limiting responsibility. Additionally, the chapter considers terms aimed at termination of services, portability and other provisions necessary for exiting services.

In addition to offering an evaluation of specific contract terms, the chapter also evaluates how governments might create better cloud computing contracts to generate more consistent and compliant results.