New York University Safety Information in Drug Approval Paper

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Attached. Please let me know if you have any questions or need revisions.Running Head: SAFETY INFORMATION IN THE FDA’S DRUG APPROVAL PACKAGE 1SAFETY INFORMATION IN THE FDA’S DRUG APPROVAL PACKAGEBy (Name)CourseProfessorInstitutional AffiliationDateSAFETY INFORMATION IN THE FDA’S DRUG APPROVAL PACKAGE2Part 1: Background informationOverview of safety basicsThe process of drug development entails multiple stages, including non-clinical andclinical studies. Clinical studies entail testing the new treatment in human beings, whereas nonclinical studies testing happens on animals. Thousands of these experiments are performed daily,generating thousands of discovery drugs and scientific publications. However, the decision toadvance or subject a drug to human testing requires a substantial body of evidence supporting theeffectiveness and safety of the concept developed (Taylor, 2015). Clinical studies are reviewedunder control procedures, while non-clinical research occurs under non-regulated environments.Both the studies must comply with regulations stated by health authorities under safetypharmacology.Safety pharmacology refers to the discipline that seeks to examine whether adrug/biologics, when administered to the population (human beings or animals), is likely to besafe or unsafe. Therefore, its the discipline’s professional mandate to conclude that the drugunder examination has sufficiently low potential to evoke adverse effects to be tested in patients(Pugsley & Curtis, 2015). On the flip side, to determine if the drug has a high potential to bebeneficial to be tested in patients. Suppose the clinical trial results prove to support both safetyand efficacy, the health authorities review all evidence to decide whether not to approve the newtreatment.Safety monitoring is an essential component in all stages of drug development. Safetymonitoring in the non-clinical and clinical development of a drug provides the evidentiaryfoundation for approval for safe and effective medicines. Moreover, the ever-increasing expensesincurred in performing clinical and non-clinical experiments detecting safety signals earlierSAFETY INFORMATION IN THE FDA’S DRUG APPROVAL PACKAGE3increase the potential of saving development cost and lead to better patient protection. Similarly,safety evaluation, primarily in clinical trials, enables the experiment to adhere to establishedstandards, therefore “protecting the participants’ rights, safety, and well-being” (NIH, 2018).Furthermore, the monitoring ensures that the pharmaceutical sponsors adhere to both local legaland regulatory requirements. Additionally, safety monitoring provides the pathway to attainingmarketing authorization and regulatory authorities, which require regulatory approval ofmedicine since evaluation from preclinical to all…

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