BUS670 Week 3 Assignment

BUS670 WEEK 3 ASSIGNMENT 1 Administrative Law [WLO: 3] [CLOs: 1, 2, 3, 4] [NACE: 1, 2, 3, 4, 5, 6] Prior to beginning work on this assignment, review Chapter 5 in your textbook and other administrative law resources. This includes U.S. Food and Drug Administration Links to an external site. and Federal Trade Commission Links to an external site. websites. You will also need to seek at least two other research sources for this assignment, which is as follows: One of the key areas of business law is the regulation of commercial activities by administrative agencies. In fact, there are so many aspects of a business that are subject to administrative rules and regulations that it is nearly impossible to operate an organization without considering how decision-making would be impacted by these. Two of the most powerful administrative agencies that regulate business are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). In your paper,  Explain the primary purpose of the agency (either the FDA or the FTC).  Describe in some detail three (3) different functions that the agency performs in the regulation of a business or industry.  Describe three (3) legal cases that the agency has been involved in. You should be able to find these on the agency website. The Westlaw Links to an external site. database would also offer another source of research for this purpose.  Analyze whether the agency unduly burdens (restricts) or provides adequate protection to business or industry. Note that the answer to these questions might make for an effective thesis statement for this assignment. The Administrative Law paper  must be 4 double-spaced pages in length (not including title and references pages) and formatted according to APA Style Links to an external site. as outlined in the Writing Center’s APA Formatting for Microsoft Word Links to an external site. resource.  must include a separate title page with the following in title case: o title of assignment in bold font

BUS670 WEEK 3 ASSIGNMENT 2  Space should appear between the title and the rest of the information on the title page. o student’s name o name of institution (The University of Arizona Global Campus) o course name and number o instructor’s name o due date  must utilize academic voice. o Review the Academic Voice Links to an external site. resource for additional guidance.  must include an introduction and conclusion paragraph. o Your introduction paragraph needs to end with a clear thesis statement that indicates the purpose of your paper. o For assistance on writing Introductions & Conclusions Links to an external site. and Writing a Thesis Statement Links to an external site. , refer to the Writing Center resources.  must use APA Level Headings, found on the Writing Center’s APA Style Elements Links to an external site. page.  must use at least 3 credible sources in addition to the course text. o The Scholarly, Peer-Reviewed, and Other Credible Sources Links to an external site. table offers additional guidance on appropriate source types. If you have questions about whether a specific source is appropriate for this assignment, please contact your instructor. Your instructor has the final say about the appropriateness of a specific source. o To assist you in completing the research required for this assignment, review Quick and Easy Library Research Links to an external site. tutorial, which introduces the University of Arizona Global Campus Library and the research process, and provides some library search tips.  must document any information used from sources in APA Style as outlined in the Writing Center’s APA: Citing Within Your Paper Links to an external site. guide.  must include a separate references page that is formatted according to APA Style as outlined in the Writing Center. o Review the APA: Formatting Your References List Links to an external site. resource in the Writing Center for specifications.

BUS670 WEEK 3 ASSIGNMENT 4 Administrative Law Businesses, both large and small, need to be supervised by administrative entities in order to ensure the protection of public interests and the promotion of ethical corporate conduct in accordance with the principles of business law. Both the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) are vital administrative bodies that have a significant impact on businesses. The FDA and FTC oversee commerce, including public health protection and fair competition. This study examines the fundamental objectives of various institutions, investigating the complexities of their roles in business regulation. Furthermore, this study critically examines prominent legal instances in which these agencies have been implicated, providing insight into the ramifications of their regulatory interventions. This study aims to conduct a critical analysis in order to determine if these agencies effectively achieve a harmonious equilibrium between the preservation of public safety and the facilitation of a favourable climate for business and industry. This study seeks to analyze the intricate relationship between administrative oversight and the viability of corporate operations by exploring their respective functions, legal engagements, and the consequences of regulatory actions. The FTC and FDA are powerful government entities that have authority over various aspects of business operations. The FDA's main mission is to protect public health. They oversee and control product quality for safety and effectiveness. This category includes food, medication, vaccinations, biopharmaceuticals, blood transfusions, radiation-emitting equipment, pet supplies, and cosmetics (Darrow, Avorn & Kesselheim, 2020). The FDA influences sectors that affect the quality of items customers buy and their health and safety.

BUS670 WEEK 3 ASSIGNMENT 5 The Food and Drug Administration (FDA) performs many essential roles in the regulation of enterprises and industries, with the aim of guaranteeing the safety and effectiveness of a wide array of products. One of the primary considerations is to the meticulous assessment and authorization procedure for novel pharmaceuticals, medical apparatus, and health-related commodities. The FDA carefully reviews scientific evidence and conducts comprehensive clinical trials to assure the safety and effectiveness of these goods before they are released. The Food and Drug Administration (FDA) is critically important in enforcing GMPs in the food, pharmaceutical, and medical device industries. The FDA ensures product

BUS670 WEEK 3 ASSIGNMENT 7 of generic medications (Reiss et al., 2013) Through the diligent examination and initiation of legal proceedings against fraudulent acts, the Food and Drug Administration (FDA) has effectively showcased its dedication to upholding ethical norms within the pharmaceutical sector. Consequently, this has contributed to the cultivation of an environment characterized by trustworthiness and dependability in the pharmaceutical industry. These legal proceedings showcase the FDA's efforts to balance regulations and public health. The agency plays a crucial role in examining industrial practices, preventing hazardous items from entering the market, and addressing fraud. This demonstrates their commitment to a regulatory system that prioritizes public welfare. The Food and Drug Administration (FDA) plays a pivotal role in upholding a delicate balance between regulatory oversight and the economic sustainability of businesses and industries. In order to ascertain if the FDA imposes undue costs or offers adequate protection, a meticulous analysis of its diverse ramifications is necessary when conducting a thorough study of its impact on enterprises. The FDA's strong regulatory framework and rigorous approval processes are presenting hurdles to businesses. The comprehensive assessment necessary for novel products, in conjunction with the adherence to Good Manufacturing Practices (GMPs), could lead to extended timeframes and increased expenses related to regulatory compliance (Yu et al., 2016). These issues above have the potential to hinder the ability of organizations, especially those of smaller scale, to put innovative solutions into the market promptly. It's important to understand that these regulations are not random. They are meant to improve the

BUS670 WEEK 3 ASSIGNMENT 8 well-being and safety of everyone. The FDA safeguards the marketplace by blocking unsafe or ineffective products (Zettler, Riley & Kesselheim, 2018). We evaluate pharmaceuticals, medical equipment, and more to ensure safety, efficacy, and quality, building trust among consumers. The FDA's regulatory barriers protect consumers by reducing potential hazards. A comprehensive analysis should acknowledge the complicated balance that the Food and Drug Administration (FDA) maintains between the interests of the industry and the welfare of the general public. While regulatory processes may provide challenges, they are essential for upholding the integrity of industries and enforcing measures to safeguard consumers. Hence, the thesis statement for this assignment could contend that notwithstanding businesses' perception of onerous regulations, the regulatory measures enforced by the FDA are indispensable in preserving public health, ensuring consumer safety, and upholding the overall integrity of industries under its purview. The objective of this study is to investigate the complex connection between regulatory requirements and their impact on business activities, specifically emphasizing the significant role of the FDA in resolving these competing interests. The FDA and businesses must find a balance between strict regulations and operational effectiveness. The FDA's strict approval process and commitment to Good Manufacturing Practices pose challenges for firms, but they are crucial for ensuring the safety and effectiveness of products in the market. It is crucial to consider the potential drawbacks, such as prolonged timeframes and heightened expenses related to compliance, in conjunction with the vital function these regulations provide in averting the introduction of hazardous goods, thus cultivating customer confidence. The commitment of the Food and Drug Administration (FDA) to safeguarding public health is clearly demonstrated by its rigorous inspection. This approach involves finding a delicate equilibrium that, while imposing significant demands on businesses,

BUS670 WEEK 3 ASSIGNMENT 10 References Allen, B. (2019). The role of the FDA in ensuring the safety and efficacy of artificial intelligence software and devices. Journal of the American College of Radiology , 16 (2), 208- 210. Cuéllar, M. F. (2011). Coalitions, Autonomy, and Regulatory Bargains in Public Health Law. Forthcoming in Preventing Capture: Special Interest Influence in Regulation and How to Limit It,(Carpenter, Croley, and Moss, eds., Cambridge University Press), Stanford Public Law Working Paper , (1974690). Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2020). FDA approval and regulation of pharmaceuticals, 1983-2018. Jama , 323 (2), 164-176. Reiss, J. B., Crowder, D., McCabe, B., & DeFeo, M. (2013). Your business in court and at Federal agencies: 2011-2012. Food & Drug LJ , 68 , 1. Yu, L. X., Akseli, I., Allen, B., Amidon, G., Bizjak, T. G., Boam, A., ... & Zezza, D. (2016). Advancing product quality: a summary of the second FDA/PQRI conference. Zettler, P. J., Riley, M. F., & Kesselheim, A. S. (2018). Implementing a public health perspective in FDA drug regulation. Food & Drug LJ , 73 , 221.