What legislation significantly changed regulations to enhance FDA authority over drug approval?

The Kefauver-Harris Amendment, enacted in 1962, significantly enhanced the authority of the FDA over drug approval processes. This legislation required that, in addition to demonstrating the safety of a new drug, manufacturers must also provide evidence of its effectiveness before it could be approved for marketing. This was a pivotal change from prior requirements, as it shifted the focus of drug approval not only to safety but also to the therapeutic benefits of the drug.

The amendment was largely a response to the thalidomide tragedy, where a drug caused severe birth defects in the early 1960s due to the inadequacy of existing regulations that did not mandate proof of efficacy. By imposing these new stringent requirements, the Kefauver-Harris Amendment aims to ensure that drugs introduced to the market are both safe and effective for consumer use, thereby increasing consumer protection and trust in pharmaceutical products and the FDA's regulatory role.

Other options, while related to drug regulation, do not represent the same level of change in the authority of the FDA concerning drug approval. The Food, Drug, and Cosmetic Act originally established the FDA's authority but was more foundational than transformative in the context of drug efficacy. The Drug Approval Efficiency Act may have sought to streamline certain processes but lacked the