Regulatory Compliance: labeling, and FDA’s issuance of Warning Letters as enforcement actions to manufacturers claiming to market products that can effectively treat Acute Respiratory Distress Syndrome (ARDS) without supporting clinical evidence

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Description A major learning outcome for the course is to enable students to explain how fundamental compliance principles are applied through analysis of a current healthcare issue from a regulatory perspective. An obvious choice would be to present an analysis of what FDA is doing about the COVID-19 pandemic – there are multiple perspectives here. These include facilitating patient access to new diagnostics and treatments. Less obvious choices might include labeling, and FDA’s issuance of Warning Letters as enforcement actions to manufacturers claiming to market products that can effectively treat Acute Respiratory Distress Syndrome (ARDS) without supporting clinical evidence. This is not to say that you must choose an aspect of the COVID-19 pandemic to complete this Assignment. In fact, you are encouraged to explore other therapeutic areas which represent contemporary challenges in healthcare, and in which FDA plays an active role. An exploration of the US Food and Drug Administration (FDA) website, as well as the mainstream media, may yield some great ideas as well. You may also choose a topic in which the FDA collaborates with other federal agencies, including the FTC or USDA. What is critical is that the topic must have current relevance, and that you can demonstrate an understanding of this topic from a regulatory compliance perspective. Instructions • You may work independently to complete this Assignment, or you may choose to collaborate with at maximum one of your classmates – if you choose the latter option please submit ONE presentation per group • Please utilize Power Point to complete and submit your analysis – your slide set should consist of 15-20 slides with audio narration to accompany each slide • Specifically, your analysis should include: 1) A description of the regulatory issue and/or challenges – this may be a US centric issue, or may be a more globally oriented issue that impacts the US 2) An explanation for why your chosen issue has regulatory compliance implications, especially from a US perspective 3) Details of FDA’s response to the issue, both historical and ongoing, including any enforcement actions taken 4) An interpretation of how FDA is likely to respond in the future to your chosen issue – are FDA’s response(s) ‘one time only’ type of responses, or are there ongoing process(es) involved. For example, when FDA issues a Warning2 Letter there is a process integrated that includes required timing and content of response(s) by manufacturers 5) Likely end stage implications – for example, will FDA’s response to the issue have a lasting impact on public policy? Is FDA’s involvement likely to lead to passage of legislation by the US Congress? Are additional compliance standards likely to be developed and implemented? 6) If you were appointed FDA Commissioner would you respond to the chosen issue in the same or different ways? Why? Your submission should include a slide to list any references used in your research and analysis. You may list these references on individual slides, as appropriate, or integrate as a bibliograpagnhy at the end of the presentation.

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