Answered step by step
Verified Expert Solution
Link Copied!

Question

1 Approved Answer

Abel Company wants to sell the vaccine delivery systems. The Food and Drug Administration system issued a new rule (after notice and comment) to any

Abel Company wants to sell the vaccine delivery systems.  The Food and Drug Administration system issued a new rule (after notice and comment) to any vaccine delivery manufacturer stating that it had to have, prior to selling any systems, a $50 million insurance policy to cover the claims of persons who were harmed by the systems.   The FDA claimed that the rule is necessary because the law stated that medical devices must be safe and insurable up to the amount of the revenues of the Company.   Abel has revenues of $50 million, but can't afford to buy a policy like that, so it challenges the rule in court.     What is the likely ruling, and why?

Step by Step Solution

3.43 Rating (153 Votes )

There are 3 Steps involved in it

Step: 1

The likely ruling in this case would be that the FDAs rule is invalid The rule requires vaccine deli... blur-text-image

Get Instant Access to Expert-Tailored Solutions

See step-by-step solutions with expert insights and AI powered tools for academic success

Step: 2

blur-text-image_2

Step: 3

blur-text-image_3

Ace Your Homework with AI

Get the answers you need in no time with our AI-driven, step-by-step assistance

Get Started

Recommended Textbook for

Ethics in Information Technology

Authors: George Reynolds

5th edition

1285197151, 9781305142992 , 978-1285197159

More Books

Students also viewed these Law questions

Question

Examine goals and determine priorities.

Answered: 1 week ago

Question

What is master production scheduling and how is it done?

Answered: 1 week ago

Question

2. In which brain areas do new neurons form in adultspg109

Answered: 1 week ago

Question

1. Which develops first, a neurons axon or its dendritespg109

Answered: 1 week ago