Which document defines the chemistry manufacturing controls needed for a new drug application?

The correct answer is the new drug application. This document is crucial because it outlines the necessary data about a new drug, including the chemistry, manufacturing, and controls (CMC) section. The CMC includes detailed information on the drug's composition, manufacturing processes, and quality control measures that ensure the product's safety, efficacy, and consistency.

In a new drug application, the applicant must provide comprehensive details about how the drug will be manufactured, including the raw materials used, the methods of production, and the quality assurance processes in place. This information is vital for the regulatory authorities to assess whether the drug meets safety and efficacy standards before it can be approved for public use.

While regulatory guidelines offer general principles for drug development and approval, they do not specify the individual chemistry manufacturing controls for each drug. The product label contains information about the drug's use and dosing but does not detail the manufacturing controls. A clinical trial report discusses the results of studies conducted to test the drug's efficacy and safety, but it does not provide the comprehensive manufacturing information included in the new drug application.