E-Articles - Relationships

Since the holidays are upon us, I thought it fitting to focus on that "joyful" time of year. It is joyful isn't it? While most people may have v

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

isions of sugar plums dancing in their heads, step-families are probably more concerned about who will be where and what they will do once they

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

Examples of combination products may in

et there. There's nothing like the holidays to give step-families a headache.

If you are in a new relationship, how will you deal with differin

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

traditions? Your new partner may have two houses to go to and you usually have three. Can you fit in all of those in the short amount of time y

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

u have AND still get the children to your ex-spouse on time?

If this is your first holiday since your divorce, you may be feeling very sad abou

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

Combination pro

not having your children with you over the entire holiday like you are used to. Your anger at your ex-spouse may be a little more intense right

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

now because this is a touchy subject for everyone. What will you do when your children are with your ex-spouse? How are your traditions going to

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

be different?

Rather than peaceful expectation, you may be pulling your hair out right about now, or you may still have your head in the sand t

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

ying to deny that you'll have to deal with all of these questions. Well, brush that sand out of your eyes so you can focus, and leave some hair

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

n your head so your relatives won't be too worried about you. The first thing to do is just acknowledge that the holidays will be different. Doe

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

that automatically mean worse? No! With some creative juggling and negotiations, this is an opportunity to develop some new traditions.

If it'

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

Following aspects would a

just you and your kids at this point, sit down with them and talk about the upcoming holidays. If they voice disappointment with things being d

dd to the challenges in developing combination products:

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

fferent, let them know you understand and if you feel the same, share that too. But, after doing this, it's time to re-focus on what the reality

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

is and try to develop some fun ways that all of you can do things different, but also maintain some of the same. Maybe instead of that Christmas

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

ham you never liked making, you could do Chinese takeout and lounge around in your pajamas instead of running here, there, and everywhere.

If y

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

u are in a new relationship and trying to merge many differing traditions, talk as a couple first about what your priorities are. Does your fami

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

Professional from academic institutions, pharmaceutical industries, health care indust

y HAVE to meet this person now? Could you have a New Year's Party or dinner party after the holidays to introduce him or her? Try to develop som

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

rough ideas together. Then talk with your respective children about what's important to them. See where you can merge ideas and then run with i

.

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

.

The truth to really hold on to in the midst of all this chaos is that while the holidays are important, don't get caught up in having to cele

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

Companies that provide selfless information through particip

rate them on the actual day. The key to making any step-family work is to be flexible.

I wish you the best of luck and the happiest of holidays

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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