Actual - Legal

Greetings to all;

A burglary crime is a crime committed when a person break

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

s into, enters unlawfully, or forcefully enters a dwelling, vehicle or othe

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

Examples of combination products may in

habitat maintained or own by another person. If you break into a home, tha

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

's a burglary. If you break into a vehicle, mobile home, storage facility, g

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

arage, etc, that's burglary. It doesn't matter if someone is home or not. Th

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

Combination pro

crime is committed because you unlawfully placed yourself in a place you ar

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

not authorized to be in.

Suppose the owner gave you permission to enter th

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

e dwelling but upon arriving, you had to use force to enter the dwelling? If

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

the owner concurs, it's not a burglary. If the owner had given you permissio

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

, but later informs the police that he did not give it, it's a burglary char

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

e. Why did I bring this odd example into play? I knew of a person that was s

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

Following aspects would a

et up like this. This is why you should be very careful taking someone's wor

dd to the challenges in developing combination products:

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

about entering anyplace without permission.

Personally for me, if their no

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

family or very good friends, I'm not going in. I rather wait until they arr

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

ive or come with me. This is a very old vindictive game played by many peopl

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

in the 30's and 40's. You simply set your enemy up. It will work today as

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

Professional from academic institutions, pharmaceutical industries, health care indust

ell as back then.

Understand that the law is based on it's written meaning.

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

A District Attorney could place you in jail for a very long time based on t

.

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

e meaning and wording of the law, not on your intent.

Be careful where you

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

Companies that provide selfless information through particip

o, what you do, and who you listen to. It's a very dangerous world out there

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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