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One of the most romantic pictures any of us can conjure up is that of two young lovers walking alon

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

g, so engrossed in each other that they have no idea whether anyone else is present or not.

Endles

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

Examples of combination products may in

s stories, poems and songs have been written about young love and gorgeous paintings have been rend

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

ered in their honor.

We have all been touched by young love at one time or another, haven't we? Mo

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

t of us personally! We smile as we remember what it felt like. Oh, the thrill of it all...

But doe

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

Combination pro

s it stop there? What of mature middle-life love with it's myriad assignments of career and parenti

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? What of the blessings that come as we measure our lives by how many great grandchildren we have

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

?

Does young love ever get old? I suggest we visit an "all care", retirement center for the answer

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

to that question. What evidence do we find that young love is alive and well as we walk around the

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

campus and visit the assisted living and nursing home facilities?

We immediately see spouses pushi

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

ng their loved ones in wheel chairs. A few minutes of visiting with them make it clean that they wo

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

Following aspects would a

uldn't want to be anywhere else. It's obvious that their being together still means a great deal.

dd to the challenges in developing combination products:

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

s we pass the nursing home dining room, several spouses are patiently feeding lifetime mates. Look

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

more closely...young love is in their eyes.

We meet couples with six and even seven decades to the

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

ir credit, holding hands as they attend a program or walk about the campus. The glow is still there

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

and it's still new.

Young love endures. Young love remains in the young-at-heart. Young love prom

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

Professional from academic institutions, pharmaceutical industries, health care indust

ses "forever" and means it...because love is always young. It doesn't have a "shelf-life".

So yes,

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

lets never forget the beginnings of love...the excitement and the wonder of it all. Oh, the thrill

.

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

of infatuation and the intoxicating breathlessness of novelty! And then lets celebrate the fact th

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

Companies that provide selfless information through particip

at it's possible to still be in love...even when dear ones have passed. Love is ageless and eternal

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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