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? 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.
Please utilize Power Point to complete and submit your analysis ·your slide set
should consist of 15-20 slides
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? 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? response(s) ?ne time only·type of responses, or are there
ongoing process(es) involved. For example, when FDA issues a Warning
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? response to the issue
have a lasting impact on public policy? Is FDA? 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 bibliography at the end of the presentation.