therapeutic areas which represent contemporary challenges in healthcare, and in which FDA plays an active ro

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 that 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 Please utilize PowerPoint to complete and submit your analysis –your slide set should consist of15-20 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 an Us centric issue or maybe a more globally oriented issue that impacts the US2)An explanation for why your chosen issue has regulatory compliance implications, especially from a US perspective3)Details of FDA’s response to the issue, both historical and ongoing, including any enforcement actions taken4)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 an ongoing process(es)involved. For example, when FDA issues a Warning

Don't use plagiarized sources. Get Your Custom Essay on
therapeutic areas which represent contemporary challenges in healthcare, and in which FDA plays an active ro
Get an essay WRITTEN FOR YOU, Plagiarism free, and by an EXPERT!
Order Essay

2Letter 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 the passage of legislation by the US Congress? Are additional compliance Are 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.

Top Grade Homework
Order NOW For a 10% Discount!
Pages (550 words)
Approximate price: -

Why Work with Us

Top Quality and Well-Researched Papers

We always make sure that writers follow all your instructions precisely. You can choose your academic level: high school, college/university or professional, and we will assign a writer who has a respective degree.

Professional and Experienced Academic Writers

We have a team of professional writers with experience in academic and business writing. Many are native speakers and able to perform any task for which you need help.

Free Unlimited Revisions

If you think we missed something, send your order for a free revision. You have 10 days to submit the order for review after you have received the final document. You can do this yourself after logging into your personal account or by contacting our support.

Prompt Delivery and 100% Money-Back-Guarantee

All papers are always delivered on time. In case we need more time to master your paper, we may contact you regarding the deadline extension. In case you cannot provide us with more time, a 100% refund is guaranteed.

Original & Confidential

We use several writing tools checks to ensure that all documents you receive are free from plagiarism. Our editors carefully review all quotations in the text. We also promise maximum confidentiality in all of our services.

24/7 Customer Support

Our support agents are available 24 hours a day 7 days a week and committed to providing you with the best customer experience. Get in touch whenever you need any assistance.

Try it now!

Calculate the price of your order

Total price:

How it works?

Follow these simple steps to get your paper done

Place your order

Fill in the order form and provide all details of your assignment.

Proceed with the payment

Choose the payment system that suits you most.

Receive the final file

Once your paper is ready, we will email it to you.

Our Services

No need to work on your paper at night. Sleep tight, we will cover your back. We offer all kinds of writing services.


Essay Writing Service

No matter what kind of academic paper you need and how urgent you need it, you are welcome to choose your academic level and the type of your paper at an affordable price. We take care of all your paper needs and give a 24/7 customer care support system.


Admission Essays & Business Writing Help

An admission essay is an essay or other written statement by a candidate, often a potential student enrolling in a college, university, or graduate school. You can be rest assurred that through our service we will write the best admission essay for you.


Editing Support

Our academic writers and editors make the necessary changes to your paper so that it is polished. We also format your document by correctly quoting the sources and creating reference lists in the formats APA, Harvard, MLA, Chicago / Turabian.


Revision Support

If you think your paper could be improved, you can request a review. In this case, your paper will be checked by the writer or assigned to an editor. You can use this option as many times as you see fit. This is free because we want you to be completely satisfied with the service offered.