Topic
Safe and effective drugs and devices are essential to our
healthcare system.  On the positive side,
these products provide critical life-saving therapies that improve patient
health outcomes and quality of life.  Moreover,
these products can provide treatment options that reduce overall healthcare
costs, thereby maximizing limited financial resources.
Unlike other consumer products (e.g., automobiles,
computers, etc.), these products have a high potential to cause significant
harm or even death.  Thus, the industry operates
in a complex and highly regulated environment, which attempts to balance the
benefits and risks to ensure that marketed drugs and devices are safe and
effective when prescribed.  
The Ask
As we have covered in this course, this highly regulated environment
creates numerous complicated legal, regulatory, and compliance challenges and
risks for drug and device manufacturers. 
This assignment asks you to address the following two (2) questions:
1.      
Based on what we covered in the course, what
are the top three (3) legal, regulatory, or compliance challenges/ risks
confronting drug and device manufacturers when developing and marketing new products?
2.      
What are the best approaches to address
the challenges/risks identified?  Please
be specific.
Instructions
For your paper, you may access any class information, but additional
outside research is prohibited.  Like
the Mid-Term and Short Paper, your evaluation will be based on your thoughtfulness,
how well you address the topic, and your understanding of the materials.  
Sources may not be needed — see the instructuons. I need a palgerism report and AI report!!!