Summary - Relationships

Getting a divorce is hard, even under the best circumstances. Whether it’s the moment you look into your spouses eyes and declare it’s over, the moment you find out your spouse is leaving, or simply the moment the signatur

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

e actually hits the paperwork, it occurs for everyone the same. This is just plain hard.

One of the biggest challenges is that both parties have different view points and are trying desperately to compromise in many areas

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

Examples of combination products may in

: finances, personal belongings and child custody rights. While they are all important, money seems to be the easiest one to fight about, because even aloud, the argument seems rational. Though while it seems the most rat

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

onal to argue about, much of the bitterness comes from: if you only knew how I felt… Myth: It is easier to be the one that is leaving, rather than being “left.”

Truth: It is difficult to accept that your marriage has fa

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

iled, no matter which side you are on. If you are being left, clearly you are not over your love for that person and wish you could stay together. Yet if you are the one leaving, you are left dealing with abandoning someo

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

Combination pro

ne, removing children from a “family unit” and the prospect of choosing to be alone. It is sad, no matter which side you are on. Just different.

So, the question is, how do you manage a civilized conversation with this p

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

rson you love or once loved, when both of you are hurt and angry with each other? It will no doubt be a challenge, but there are strategies that can help.

1 - Take a step away from how you feel now and remember that at on

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 time in your life, you were certain this was going to be the one you loved forever. Try to visualize the love you had. Feel it and embrace it. Remember that it is what got you to where you are in your life right now.

2

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

- Consider that if you are the one leaving, your spouse has not had time to prepare for this emotionally, even if you’ve been fighting for years. So you’re place of forward action may not be where he/she is yet. Be consid

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

rate that they my need some time to process before making any decisions.

3- Consider that if you are the one being left, your spouse has no doubt been feeling the same hurt you are feeling now, but has been experiencing it

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

for quite some time. It only looks abrupt because this may be the first time you are aware of it.

4- Acknowledge that you are both hurt. The person leaving is hurt because they feel they weren’t getting what they needed

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

Following aspects would a

. The person being left is hurt because they weren’t ready to stop loving yet. Either way you look at it…the anger that is coming out is simply a reaction to the pain.

5- Try to remove yourself emotionally when dividing

dd to the challenges in developing combination products:

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

p personal belongings. Simplify everything the best you can and be reasonable. Listen to his/her words without trying to interpret what is really meant by it. It is just a couch. There may be many memories attached to th

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

e couch, but when it comes right down to it, it is just a couch. Is it worth fighting about?

6- Fighting over custody arrangements is a simple one. Just don’t do it. Your children were brought into this world by both of

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

you, and deserve to have the impact of both of you in their lives forever. Even if you parent differently and don’t agree with how the other one parents, they are still an important part of your child’s’ life. Remember t

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

at just because you have declared you don’t want to live with this person, your children have not declared that and should not have that declared for them.

7- Most importantly, when things begin to get heated, sit back and

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

Professional from academic institutions, pharmaceutical industries, health care indust

take a deep breathe and try to imagine if you were on the other side of the table. Take a deep breathe and remember what remains true: I am sorry this marriage didn’t work and don’t want to hurt you.

Divorce should not

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

be a vindictive thing to do, but an action needed in your life so you can move forward and ultimately find happiness. If you feel anger and rage towards yours spouse, I recommend seeking counsel or finding a Life Coach to

.

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

elp you sort through the next stages in your life. Compromise will be difficult until you can let go of the anger, and will be an emotional roller coaster for many months, but all you need is a few hours a week, where you

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

Companies that provide selfless information through particip

can be reasonable and rational and find a happy medium.

The sooner you can get to a place of reason, the sooner both of you will find happiness, which should be the ultimate goal of divorce, no matter which side you are on

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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