Arizona MPJE (Pharmacy Jurisprudence) Practice Exam 2025 - Free Pharmacy Law Practice Questions and Study Guide

The Waxman-Hatch Act of 1984, formally known as the Drug Price Competition and Patent Term Restoration Act, was pivotal in promoting the availability of generic drugs. Under this legislation, the Abbreviated New Drug Application (ANDA) process was established. ANDAs allow manufacturers to seek approval for generic versions of previously approved brand-name drugs without the need to conduct expensive and time-consuming clinical trials. Instead, applicants need to demonstrate that their generic drug is bioequivalent to the brand-name counterpart, thus significantly streamlining the approval process.

This act was crucial in increasing market access for generics, fostering competition among drug manufacturers, and thereby leading to lower drug prices for consumers. The focus on the ANDA underscores the legislation's intention to facilitate the entry of generic products into the market efficiently and safely.

The other types of applications mentioned, such as NDA (New Drug Application), IND (Investigational New Drug), and BLA (Biologics License Application), serve different purposes in the drug approval process and are not specific to the expedited process for generics established by the Waxman-Hatch Act.