Regulatory Affairs Certification (RAC) Practice Exam

Which document must be submitted alongside a New Drug Application for a new chemical entity?

1. Drug Master File.

2. Prescribing information.

3. Informed consent documents.

4. Patient medication guide.

The correct answer is: Prescribing information.

For a New Drug Application (NDA) concerning a new chemical entity, the submission of prescribing information is essential. This document, often referred to as the label or package insert, contains details about the drug’s indications, dosage and administration, contraindications, warnings, potential side effects, and other essential clinical information that should be conveyed to healthcare providers and patients. The prescribing information is critical for regulatory review and ensures that healthcare professionals have the necessary information to prescribe the drug safely and effectively. While a Drug Master File includes information related to the manufacturing process and controls for a drug substance or drug product, it is not mandatory to submit it alongside the NDA. Informed consent documents pertain to clinical trials and the ethical process of obtaining agreement from participants to engage in research; they are not part of the NDA submission. A Patient Medication Guide, designed to inform patients about using the drug safely, may be required for specific drugs but is not universally mandated for all NDAs and is not submitted in conjunction with the NDA as a requirement. Thus, the requirement to submit the prescribing information emphasizes its vital role in ensuring safety and efficacy is communicated accurately to those who will be using the drug in clinical practice.