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505(b)(2) Pathway

Meaning

The 505(b)(2) Pathway represents a specific regulatory route for New Drug Applications (NDAs) established by the U.S. Food and Drug Administration (FDA). This mechanism permits a pharmaceutical company to seek approval for a new drug formulation or indication by relying, in part, on the FDA’s prior findings of safety and efficacy for a previously approved drug. It is a streamlined process that avoids the full replication of extensive, time-consuming clinical trials, accelerating the availability of therapeutic modifications. For the hormonal health space, this pathway is frequently utilized to bring novel delivery systems or new combinations of bioidentical hormones to market efficiently.