South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What streamlined process was established for generic drugs under the Hatch-Waxman Amendment?

1. Abbreviated New Drug Application (ANDA)

2. New Drug Application (NDA)

3. Biologics License Application (BLA)

4. Generics Approval Process (GAP)

The correct answer is: Abbreviated New Drug Application (ANDA)

The Abbreviated New Drug Application (ANDA) was established under the Hatch-Waxman Amendment to facilitate a streamlined process for the approval of generic drugs. Prior to this amendment, the process for bringing a generic drug to market was significantly more burdensome, often requiring the same extensive data and trials that were needed for the original brand-name drug. The ANDA process allows manufacturers to demonstrate that their generic drug is bioequivalent to the branded counterpart, focusing on manufacturing and labeling instead of requiring the submission of full clinical trial data. This significantly reduces the time and resources needed for approval, encouraging market competition and increasing patient access to more affordable medication options. The intention behind the Hatch-Waxman Amendment was to balance the need for innovation in drug development with the need to ensure that generic drugs could swiftly enter the market after the patent expiration of brand-name drugs. This legislative change has had a major impact on the pharmaceutical industry by promoting the availability of lower-cost generics. In contrast, the New Drug Application (NDA) is comprehensive and is used for new drugs, while the Biologics License Application (BLA) applies to biologic products. The Generics Approval Process (GAP) is not an officially recognized term in the regulatory