What is required for a new drug application?

A new drug application (NDA) is a comprehensive submission to the FDA that includes extensive data required to demonstrate that a new drug is safe and effective for its intended use. One of the critical components of an NDA is the documentation regarding the chemistry, manufacturing process, and controls (CMC). This information is essential because it ensures that the drug can be consistently produced and manufactured to meet quality standards.

The CMC component includes detailed descriptions of the drug’s formulation, the manufacturing processes used, the various controls in place during production, and the stability of the drug. This information is vital not only for establishing the drug’s safety and efficacy but also for quality assurance throughout the drug's lifecycle. It ensures that patients receive a product that remains consistent in its effect and meets the necessary safety standards.

While patient consent forms, marketing strategies, and cost analyses can be important in the broader context of drug development and commercialization, they are not required components of an NDA submission. The focus of an NDA is firmly on the safety, efficacy, and manufacturing aspects of the drug, which is why the documentation related to chemistry, manufacturing, and controls is the correct answer.