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When you are standing at the altar saying “I do” with 300 of your friends and family around you, the very last thing on your mind is the possibili

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

ty of a divorce in your future. Damn the statistics, it cannot happen to me, you think.

Think again. Recent studies have shown that the divorce

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

Examples of combination products may in

rate is almost at the 50% mark for couple being married in the past 5 years. What is the cause of that? Are people being too reckless with their

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

commitments? Do people really think that the love they feel will see them through anything?

The biggest problem leading to divorce is a lack of

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

ommunication between the partners. It really is a partnership, where each needs to know what the other is doing and thinking on a regular basis,

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

Combination pro

s in daily. You need to make sure that you are both marching to the same drummer with the same goals in sight, both short term goals as well as l

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

ng term goals, and without that communication, divorce is almost inevitable.

Is this a difficult thing? It should not be, but in today’s world w

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

ere most households have both spouses working, it can prove to be difficult. When both spouses arrive at home after a long hard day at work, both

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

are tired, perhaps irritable, neither feels like fixing dinner, and communication can often be the last thing on either one’s mind. Yet if that c

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

mmunications does not happen, it is inevitably that the two of you will take different paths, start creating separate goals, and pretty soon you f

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

nd that divorce is the only viable answer, since your paths have parted so widely that there is little chance your paths will ever rejoin.

Divorc

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

Following aspects would a

can be a comparatively simple procedure or it can be long and drawn out. It is in your best interests to get a good divorce lawyer. Really? Ye

dd to the challenges in developing combination products:

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

really. If the communications between you and your spouse have broken down to put you on separate paths, you cannot be sure of what your spouse

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

ill require or demand in the divorce process. Make sure you do not get hosed in that process, and without a good divorce attorney, that can easil

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

happen before you are even aware of it.

Things can get messy if children are involved or there is a fair amount of capital holdings that were ac

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

uired since the wedding day. But even these items can be negotiated and worked out with good divorce attorneys, plus the desire to “just get it o

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

Professional from academic institutions, pharmaceutical industries, health care indust

er with peacefully” on the part of both spouses.

If divorce is really the best or only option available to you, plan it with the same attention t

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

detail that you used when you planned your wedding. Preparation and a thorough knowledge of what is involved and what can be negotiated is param

.

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

unt in making sure that you don’t walk away with absolutely nothing. Almost anything is negotiable as far as “who gets what”, but be very clear o

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

Companies that provide selfless information through particip

what are your rights, what are the rights of your spouse, and how to effectively manage the division of assets, including cash, stocks, and bonds

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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