South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which entity evaluates and approves drug applications under the ANDA process?

1. Federal Trade Commission

2. Food and Drug Administration

3. Drug Enforcement Administration

4. Department of Health and Human Services

The correct answer is: Food and Drug Administration

The Food and Drug Administration (FDA) is the entity responsible for evaluating and approving drug applications under the Abbreviated New Drug Application (ANDA) process. This process allows applicants to demonstrate that their generic drug is bioequivalent to a brand-name drug, ensuring that it is a safe and effective alternative. The FDA’s role involves reviewing data on the drug's chemistry, manufacturing, and controls, along with labeling and clinical data, which are crucial to ensuring public health and safety. The FDA's rigorous evaluation process helps maintain the standards for drug efficacy and safety, which is vital in allowing generics to enter the market while offering patients affordable access to necessary medications. This function is part of the broader responsibilities of the FDA, which oversees various aspects of drug development and regulation in the United States. In contrast, the other entities mentioned have different roles: the Federal Trade Commission primarily deals with protecting consumers and competition, the Drug Enforcement Administration focuses on controlling and regulating drugs that have the potential for abuse, and the Department of Health and Human Services encompasses a wider array of health-related policies and services, but does not specifically handle drug application evaluations.