Understanding the Drug Approval Process: A Healthcare Report

This report provides an overview of the drug approval process, focusing on the stages and regulations involved. It begins with the conceptualization of a drug and progresses through pre-clinical development, which involves in vitro and in vivo testing. The report then details the role of the Food and Drug Administration (FDA) and the stages of clinical trials: Phase I, which involves healthy volunteers; Phase II, which involves a small number of patients; and Phase III, involving a larger patient group to demonstrate safety and effectiveness. The report also references relevant literature, including a case study and research from Dimasi, Grabowski, and Hansen, along with Van Norman and Arrowsmith and Miller, to provide a comprehensive understanding of the drug development and approval process. The report highlights the critical role of the FDA in ensuring drug safety and efficacy, as well as the legal frameworks that govern the process.

Running head: DRUGS
Student affiliation
Title: Stages of Approval for Pharmaceutical Drugs

DRUGS
The way drugs are developed, produced, marketed and how medical devices and
pharmaceuticals is all about paradoxical strategies, whereby effective treatment has to reach
the public at the right time and protect them from any ineffective therapies. These goals are
also designed to protect the public against exploitative marketing practices who could sell
harmful and unauthorized drugs to vulnerable people (Van Norman, 2016). In the US the
Food and Drug Administration (FDA) obliged by law to provide regulatory measures on
foods and drugs. Since the previous century, the FDA has experienced a metamorphism due
to changes and expansions in the federal regulations that have increased the complexity of
drugs, hence changing the pharmaceutical industry in US.
Before a drug reaches the researcher, they have to follow a common path:
conceptualization of the drug, pre-clinical development (which involves in vivo and in vitro
examination) and coming up with the drug prototype. As soon as the drug can be used for
clinical study, even before human testing, the FDA must be involved (Arrowsmith and
Miller, 2013). According to federal law, for a drug to be shipped across the state, it subjected
to an approved marketing application. The manufacturer files an investigational new drug
with the relevant agency.
Drug development involves studies to determine the drug’s safety and effectiveness
for the work it was intended for and also to determine if it is well labeled. It is divided in t 3
phases: phase I-health volunteers take the drug then tests are carried out to find
pharmacological information; phase II involves a couple of patients and here evidence on the
effectiveness and drug-response characteristics are recorded (Dimasi, Grabowaski and
Hansen, 2016); phase III, involves more patients and the safety and effectiveness of the drug
are demonstrated in the hospital. To shepardize a pharmaceutical drug case (FDA vs. H.
Slaughter) with citation 573 S.E.2d 785, the results showed that the case was reaffirmed.

DRUGS
References
Arrowsmith, J., & Miller, P. (2013). Trial watch: phase II and phase III attrition rates 2011–
2012. Nature Rev Drug Discov, 12 (2013), p. 569
Dimasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical
industry: new estimates of R&D costs. Journal of health economics, 47, 20-33.
Van Norman, G. A. (2016). Drugs, Devices, and the FDA: Part 1: An Overview of Approval
Processes for Drugs. JACC, Vol. 1, No. 3, pp. 170-179. Doi:
https://doi.org/10.1016/j.jacbts.2016.03.002