Final answer:
The drug therapy management under protocol statute involves setting best practice standards for safety in medication management, with Directly Observed Therapy as one method. The FDA oversees the clinical trials and approval process ensuring safety and efficacy of new therapies.
Step-by-step explanation:
Drug therapy management under protocol statute primarily revolves around setting best practice standards for risk and safety assessments related to medications. Specifically, within two years of a particular order, the Secretary is required to outline practices that address, among other things, substance abuse and domestic violence in the context of drug therapy. One example of managing drug therapy effectively is through directly observed therapy (DOT), which is a means of ensuring patients comply with their medication regimens. DOT can be quite effective but also introduces additional complexities regarding accessibility, cost, and adherence. The process of introducing a new therapy involves significant testing, starting with animal trials, progressing through various clinical trials, and continuing on to human subjects before seeking FDA approval. This entire process is overseen by the FDA's Center for Drug Evaluation and Research (CDER), which ensures that all therapies meet the required standards for efficacy and safety before they are approved for market release.