ABSTRACT
Project Management in the pharmaceutical and medical device manufacturing industries follows a more technical/formal path, especially in the design stages of the products. The pharmaceutical company is responsible for submitting periodic reports to the Food and Drug Administration (FDA) regarding any unknown side effects that may occur after approval. The iterative development process eliminates the sequential aspect of the waterfall process and allows for more flexibility and interaction, particularly with the customer. Managing projects such as the development of medical devices or new drugs, whether traditional or “proactive,” has its own set of issues and procedures. The FDA’s role in the preclinical research stage is minimal. However, once a company finds sufficient evidence that a drug is successful in animals, human trials will begin. The FDA plays a much more crucial role during the various clinical trial phases.
