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The tort of negligent entrustment in simple language means that you were negligent by allowing a person or persons

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

to use your property such as a car, motorcycle, etc.

Negligence is a legal term of art. It would be very difficu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

lt to explain negligence to a non-attorney. However I will try.

Negligence in simple language, is that one person

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

owes a duty of due care to another person, and breaches that duty of due care thus causing damages. The key to neg

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ligence is that it must be reasonably foreseeable to an ordinary prudent person that the conduct will result in da

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ages. I will be frank, negligence is much more complicated than the description I just gave, however it will suffi

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ce for the purposes of this article.

An example of simple negligence would be one person not paying attention and

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

rear ending another person in their car. The person who did the rear ending would be liable in most circumstances

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

for negligence.

With respect to negligent entrustment, I will give you an example of where you could be held liab

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e for this tort. Let's say you loan your car to a person who has a suspended driver's license. Let's say this pers

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

on subsequently gets into a car accident. You would most likely be held liable for the damages caused in the accid

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ent, because you owed a duty of due care to ensure that you did not loan your car to a person with a suspended dri

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

er's license. In other words, you were negligent by allowing a person with a suspended drivers license to use your

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

car.

Another example would be loaning your car to a person who was obviously intoxicated, who then subsequently

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ets into an accident. You can be held liable for negligent entrustment for loaning you car to a drunk.

There is a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

vast array of possible scenarios in which you could be liable for the tort of negligent entrustment. It's not roc

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

et science, it's really about common sense. The purpose of this article is just to make you aware of the tort.

Ba

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

sically it's a matter of common sense. If you are going to loan a person your car, motorcycle, or other property,

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ou better make sure they have a driver’s license and automobile insurance before you give them the keys unless you

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

're not concerned about being legally liable for their actions.

By Norman Gregory Fernandez, ESQ. , Copyright 200

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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This morning before breakfast I checked my email and found an extra hundred dollars in one of my accounts. It was revenue from sales of one of my ebooks overnight.

The other day I happened upon a site where I was invited to subscribe to the webmaster's ezine. All good and well and of course good marketing to have a subscribe page and way of capturing visitors emails on your site. But the webmaster purported to say that the newsletter had a value of $399 but I would be one of the lucky ones and get it for free.

In my opinion trading is the most exciting and best way to earn a living in the world. With just a small amount of equipment and space you can do it from anywhere on the planet.

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