Answers - Legal

This is a good question. It's asked of me more than any other questions

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

.

These are examples of criminal matters:

Robberies, rapes, murders,

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

Examples of combination products may in

all thefts, burglaries, dui's, batteries, sex crimes, etc.

These are e

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

amples of civil matters:

Repossesion of any properties, garnishments,

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

rental disputes, etc.

The best way to tell if a charge, allegation, or

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

Combination pro

matter is civil or criminal in nature is to research the penalty. In ot

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

her words, if the penalty can result in jail time, it's a criminal matt

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

er. If the penalty is a fine or loss of the subject at hand, that's civ

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

l.

Please keep this in mind though, in rare circumstances a civil matt

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

er can end up criminally.

An example: You purchase a vehicle, can't pa

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

the car note, and a repossesion order is placed on your vehicle. The '

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

Following aspects would a

repo' man comes to take possesion. As he begins to take your vehicle yo

dd to the challenges in developing combination products:

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

u get into a physical struggle with him to prevent it. You hit him! Now

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

you can be charge with battery. Your best defense in this kind of circu

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

mstance is to let him have it. You can always purchase another vehicle.

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

It's not worth it to go to jail and STILL lose your vehicle.

The above

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

Professional from academic institutions, pharmaceutical industries, health care indust

example can also apply with garnishments, rental disputes or any other

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

matter. The important thing to remember is not to escalate the civil m

.

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

tter into a criminal matter. In most cases you will still lose coupled

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

Companies that provide selfless information through particip

with jail time. Not worth it!

Take care, drive safe, and obey the laws

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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