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If you have a lot of assets, and you are worried about the financial consequences

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

of getting divorced, you may want to consider a pre-nuptial agreement.

I’m not su

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

Examples of combination products may in

ggesting you get a pre-nuptial agreement, nor am I suggesting how such an agreemen

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

t should be structured. That is between you, your attorney, and your financial adv

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

sors.

However, if you are going to pursue a pre-nuptial agreement, consider the f

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

Combination pro

ollowing:

For such an agreement to be valid, you must have all the documents in b

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

oth English and Russian. They must be certified translations of the documents in b

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

th languages.

You should have an attorney present to represent your future wife a

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

s well as one for yourself. The attorney representing your future wife should be f

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

luent in both English and Russian so he can explain everything to her.

If you are

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

serious about a pre-nuptial agreement or a post-nuptial agreement, don’t get cheap

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

Following aspects would a

with this process. If you don’t have a competent attorney representing your futur

dd to the challenges in developing combination products:

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

e wife, and if she didn’t understand what she is signing, the agreement may be dis

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

qualified.

So don’t buy a “do it yourself pre-nuptial agreement kit” or try to cu

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

corners in the process, or you may end up with a whole lot of nothing.

Consideri

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

ng the affect a pre-nuptial agreement is going to have on your wife’s attitude any

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

Professional from academic institutions, pharmaceutical industries, health care indust

way, a botched job could put you in even worse shape than not having one in the fi

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

st place.

If you are rich enough to need a pre-nuptial agreement, you can afford

.

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

to do it right. It always amazes me when I hear of guys going cheap on things that

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

Companies that provide selfless information through particip

are vital. Would you buy a life support system or shark cage on the discount isle

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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