Assignment: 

Based on the information provided below, prepare an essay discussing a proposed rule on the Federal Register website (https://www.federalregister.gov). 

Prompt: 

An important responsibility of Regulatory personnel is to understand the regulatory landscape pertinent to company operations, and to advise the company on how to remain compliant. For example, understanding the intricacies of procedures and expectations of global health authorities in clinical trial start-up will allow a company to efficiently ship a drug to clinical trials sites and study its safety and efficacy in human subjects. A strong Regulatory group will help the company to avoid delays associated with incomplete or inadequate Clinical Trial Authorization applications. A strong Regulatory group may help the company to remain in good standing with the FDA as well as the pubic by helping to report adverse events within defined timeframes and promoting the drug in an accurate and scientifically valid manner. In addition to understanding FDA’s current thinking on a given topic, Regulatory personnel should help to influence and shape the expectations and procedures set forth by regulatory authorities. One way to do this is to submit comments and feedback on proposed rules. Visit the Federal Register website and search for a proposed rule currently in the comment period. In your essay, summarize the proposed action, discuss its purpose, and indicate any important dates by when comments are due. Consider including and justifying an opinion as to whether the proposed rule you have chosen should be abandoned, amended, or enacted.