Which law allows manufacturers to submit ANDAs to market generic drugs?

The Hatch-Waxman Act of 1984 is significant legislation that facilitates the process by which manufacturers can submit Abbreviated New Drug Applications (ANDAs) to market generic drugs. This act was specifically designed to encourage the development of generic medications while ensuring that the approval process does not require the same amount of time and resources as that for new brand-name drugs.

Under the Hatch-Waxman Act, generic manufacturers canprove that their products are bioequivalent to the brand-name drug, allowing them to bypass the extensive clinical trials required for new drug applications. This not only accelerates the availability of lower-cost alternatives to consumers but also increases competition in the pharmaceutical market, ultimately benefiting public health.

The other laws mentioned—such as the Food, Drug, and Cosmetic Act, which provides the foundational framework for drug regulation in the U.S., the Controlled Substances Act, which regulates substances with potential for abuse, and the Drug Approval Modernization Act, which aimed to streamline the drug approval process—do not specifically address the submission of ANDAs for generic drugs in the same targeted manner as the Hatch-Waxman Act.