Regulatory Affairs Certification (RAC) Practice Exam 2026 - Free RAC Practice Questions and Study Guide

The correct answer is biologics, which indeed require a New Drug Application (NDA) for marketing approval. Biologics encompass a wide range of products derived from living organisms and include vaccines, blood products, and gene therapies. The NDA process is crucial for these products because it involves rigorous review of clinical data to demonstrate the product's safety and efficacy, which is essential given the complexities of biologic products. The FDA's regulatory framework mandates that any biologic intended for human use must obtain marketing approval through well-defined pathways to ensure public safety.

Cosmetics, while subject to regulation, do not require an NDA; they must be safe for use but do not require pre-market approval. Class I devices are typically low-risk and often exempt from pre-market review. Chemical agents are also not subject to NDA requirements, as they can fall under different regulatory frameworks based on their intended use and classification.

Understanding the regulatory pathways for different products is critical in regulatory affairs, especially when determining what kind of application is required for market entry.