What is a key component of a New Drug Application (NDA)?

A key component of a New Drug Application (NDA) is comprehensive data on the drug's safety and efficacy. This data is critical because it provides the evidence necessary for regulatory bodies, such as the FDA, to assess whether the drug meets the required standards for approval. Safety data includes the results from clinical trials that detail any adverse effects observed in participants, while efficacy data demonstrates how well the drug performs in treating the intended condition.

This information is gathered through extensive clinical testing, which consists of various phases designed to evaluate not only the drug's effectiveness but also its safety in a population before it is made widely available. Without robust evidence supporting both safety and efficacy, a drug application would not successfully satisfy regulatory requirements for approval.

The other options, while they may play a role in the broader context of drug development and marketing, do not constitute foundational elements that directly influence the regulatory assessment of a drug's application for market authorization. Hence, they are not considered key components of an NDA in the same way that safety and efficacy data are.