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What would marriage be if not for the annual celebratory ritual we have all come to know as the anniversary? Today, an anniversary is right up there with the biggest money-making gift-giving holidays, but it wasn’t always this way.

Ce

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

nturies ago, a married couple really only celebrated the true milestone years – those years for which two of the most precious metals were given. If a couple lasted 25 years together, they gave to one another the gift of silver. And if

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

Examples of combination products may in

they lasted 50 years, gold was their reward.

Back then, staying married 25 or 50 years was much easier than it is today, if you were lucky enough to live that long. In fact, staying married was practically mandatory as divorce was vi

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

rtually unheard of back in the “Dark Ages” (and even, ironically, during the “Age of Enlightenment”). Couples used to stay together regardless of their love for one another.

Today it’s a whole different story. Hardly anyone gets gold

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

or silver anymore because few individuals make it that far in marriage. It’s amazing the number of once-married couples that don’t even get to scratch their 7-year itches! I remember how shocked I was to find out how many of my classma

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

Combination pro

tes already had been divorced by the time we had all gotten together for our 10-year class reunion.

Today’s soaring divorce rate is probably the reason why those “Anniversary Gift” guides have been so frequently updated to better refl

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

ect “modern” times. With married couples lasting fewer and fewer years, there’s been a push to get the “good” gifts much sooner. Have you noticed? Now you can get diamonds as early as your 10-year wedding anniversary! Diamonds are prob

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

ably a much better gift than tin, but you weren’t supposed to get another diamond until your 60th anniversary! Makes you stop and think who’s behind all this change.

All joking aside, an anniversary is supposed to be an important time

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

. It’s supposed to be a time to cherish and a time to reflect back on what brought two people together in the first place. Now I’m not talking about the sex on the beach or the fuzzy nipples or the screaming orgasms (I’m talking here a

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

bout the alcoholic beverages so get your mind up out of the gutter!); I’m thinking of the camaraderie, the flirtation and the spontaneity.

An anniversary is also supposed to be a time to look towards the future, to make plans and goal

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

and to chart a course for your future together. Looking forward and back are the main reasons why it’s important to cherish our anniversaries.

Let’s face it. If you’re married, regardless of whether it’s been 20 years or you’re comin

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

Following aspects would a

g up on your very first anniversary, there’s a good chance the two of you have changed since that big day. No one is sure how or why this transformation takes place once marriage occurs, but it does, and it often does so without notice

dd to the challenges in developing combination products:

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

.

The kids, the jobs, the bills, the rat race, the (imagined or real) loss of freedom, the never-ending stresses and demands on our time cause us to lose track of the individuals we once were. We stop learning about one another, we st

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

op going out on dates, and we nag and complain and get angry at one another for seemingly trivial issues.

Once a year, anniversaries give us an opportunity to remember the love and attraction that once was. Of course, walking down mem

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

ory lane can only happen as long as the anniversary date isn’t forgotten. If it is, then that’s a whole other story!

Which is another good reason why it’s important to cherish our anniversaries. Any person who forgets an anniversary w

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

ill end up regretting that memory lapse in more ways than he or she can imagine! And rightly so. In today’s automated society, there’s really no excuse for forgetting your anniversary.

Another reason why it’s important to cherish our

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

Professional from academic institutions, pharmaceutical industries, health care indust

anniversaries is because there are few other times during the year when extravagance and excess can be excused. In other words, an anniversary is a great excuse for spending absurd amounts of money on dinner and jewellery and all those

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

other gifts that would otherwise be banned from the budget.

It really is no wonder that the traditional anniversary gift list has been updated. It’s kind of difficult to think of a useful gift, a gift that both parties will appreciat

.

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, that’s made out of paper, or linen, or cotton. When each year’s gift suggestions revolve around precious gemstones, as they do on today’s “modern” anniversary gift lists, a quick trip to the jeweller’s is all it takes to come up wit

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

Companies that provide selfless information through particip

h something suitable for the occasion.

And this is yet one more reason why it’s important to cherish our anniversaries. It’s the one thing we can do to help keep the greeting card industry and the jewellers prosperous all year ‘round!

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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