Regulatory Affairs Certification (RAC) Practice Exam

Which type of products require a New Drug Application (NDA) for marketing approval?

1. Cosmetics

2. Biologics

3. Class I Devices

4. Chemical agents

The correct answer is: Biologics

A New Drug Application (NDA) is specifically required for the marketing approval of new drugs, which typically includes pharmaceutical products intended for therapeutic use. Biologics, which consist of a wide range of products derived from living organisms, including vaccines, blood products, and gene therapies, fall under this category because they are intended to produce a therapeutic effect. The process for biologics is similar to that for new drugs, necessitating comprehensive data submission on safety, efficacy, and manufacturing quality to ensure that they meet regulatory standards before being allowed on the market. In contrast, cosmetics do not require NDA approval since they are defined by their intended use as products applied to the body for cleansing, beautifying, or altering appearance and do not require the same level of evidence for safety and efficacy as drugs. Class I devices, typically involving low-risk medical devices, are usually exempt from premarket notification or may require a 510(k) rather than an NDA. Chemical agents, depending on their classification, may not fit the criteria of needing a NDA as many are regulated differently based on their intended use and risk profiles. Thus, the necessity for an NDA is distinctly aligned with biologics that require comprehensive evaluation before being marketed.