South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the regulatory body that responds to NDA submissions?

1. Environmental Protection Agency (EPA)

2. Department of Health and Human Services (HHS)

3. Food and Drug Administration (FDA)

4. Federal Trade Commission (FTC)

The correct answer is: Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is the regulatory body responsible for responding to New Drug Applications (NDAs). The FDA's primary role is to evaluate the safety and efficacy of drugs before they can be marketed to the public. When a pharmaceutical company submits an NDA, it is seeking formal approval to begin selling a new drug based on data demonstrating that the drug is safe for human consumption and effective for its intended use. The FDA reviews the comprehensive data included in the NDA, which encompasses clinical trial results, manufacturing processes, labeling, and proposed use indications. The agency may also consult with external advisory committees and experts to ensure that its decision is well-informed. After the review, the FDA can either approve the NDA, request additional information or studies, or deny the application based on concerns about safety or efficacy. In contrast, the other agencies listed do not have the authority to approve NDAs: the Environmental Protection Agency (EPA) primarily addresses environmental health, the Department of Health and Human Services (HHS) oversees public health programs but does not directly approve drugs, and the Federal Trade Commission (FTC) focuses on protecting consumers and maintaining competition, which includes regulating advertising but not the drug approval process.