Which legislation was created to provide fast-track reviews for some NDA submissions to expedite the approval of new drugs for life-threatening conditions?

The Food and Drug Administration (FDA) Modernization Act of 1997 introduced several provisions aimed at increasing the efficiency of the drug approval process. Among its key initiatives was the implementation of fast-track review procedures for New Drug Applications (NDA) that target serious or life-threatening conditions. This legislation allows the FDA to expedite the review process for drugs that fill an unmet medical need, thereby facilitating quicker access to therapies for patients with urgent medical issues.

This fast-track designation can help prioritize the development and review of promising therapies, which is crucial in addressing conditions where time is of the essence. By streamlining the approval process, the FDA can quickly bring important drugs to market, potentially saving lives and improving health outcomes.

In contrast, the other legislative acts listed have different objectives. The Orphan Drug Act of 1983 focuses on providing incentives for the development of drugs for rare diseases, while the Prescription Drug Marketing Act of 1987 regulates the distribution of prescription drugs to ensure their safety and efficacy. The Pure Food and Drug Act of 1906 was one of the earliest forms of consumer protection legislation, aimed at preventing mislabeling and adulteration of food and drugs but does not address fast-track approvals for new drugs.