Food and Drug Agency’s Drug Approval Process

Abstract
The drug approval process of the Food and Drug Agency for pharmaceuticals is a complex and often lengthy one. Done out of necessity to ensure the products being introduced into the growing healthcare field are overall safe and effective for utilization by patients. While the process is far from perfect it still a staple in introducing innovative and breakthrough drugs into healthcare fields across the board. This paper will discuss the process encountered to get pharmaceuticals approved for manufacture and distribution to physicians and patients.

Food and Drug Agency’s Drug Approval Process
“For healthcare technology, the most important regulatory approval comes from the federal Food and Drug Administration (FDA)” (Williams & Torrens, 2008, pg.28). This agency approves all drugs and pharmaceuticals, medical devices, and some medical equipment. The FDA also controls access to drugs by deciding whether a certain drug will be available by prescription only or as an over-the-counter purchase (Shi & Singh, 2013, pg.115). The most well-known regulatory review of medical technology is that conducted on pharmaceutical products and to some medical devices that are subjected to detailed preliminary approvals, clinical trials, and post-approval surveillance policies. Before a drug can begin (first phase) clinical testing, the sponsor of the drug must evaluate the product’s safety and biological activity via in vitro and in vivo lab (animal) testing. If product appears to have important biological activity and may be useful as a drug, special test are done to evaluate its safety in the major organ systems. These studies are conducted in animals to ensure a drug is safe enough to be tested in humans. At minimum the sponsor is required to develop a pharmacologic profile of the products effects, determine its