Regulatory Affairs Certification (RAC) Practice Exam

Which of the following is NOT required in a Biologics License Application (BLA) but is required in a New Drug Application (NDA)?

1. FDA form 3397 user fee cover sheet

2. Chemistry section

3. Patent certification

4. Field copy certification

The correct answer is: Field copy certification

In the context of regulatory submissions to the FDA, a Biologics License Application (BLA) and a New Drug Application (NDA) have distinct requirements tailored to the nature of the products being reviewed. The correct answer indicates that field copy certification is not a requirement for a BLA. Field copy certification is a specific requirement associated with NDAs. It ensures that the copy of the application submitted to the FDA accurately reflects the information in electronic submissions and is accessible for review by agency personnel. The complexity of drug submissions necessitates this certification more explicitly for chemical entities, which is why it appears in the requirements for NDAs. In contrast, biologics, which include vaccines, blood products, and other complex molecules, do not require this particular certification in their BLA submissions. The regulatory framework for biologics emphasizes different aspects of the application, including manufacturing processes and product characterization, rather than a strict certification of the document copy itself. While other elements such as the FDA form 3397 user fee cover sheet, the chemistry section, and patent certification are indeed required for both applications, field copy certification stands out as a specific NDA requirement that is not applicable to BLAs. This distinction helps to streamline the review process for biologics and accommodates the differences