CAPM Practice: Demonstrate an understanding of the various project life cycles and processes

Fatou Fujimoto is managing a software development project at Wavelength Biotech. During a meeting, she identifies that user requirements may change as clinical trials progress, the regulatory approval timeline is fixed at 18 months, and there is uncertainty about whether a key vendor can deliver on time. She also notes that a competitor recently launched a similar product. How should Fatou categorize these items?