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The invasion had begun. It was right out of “War of the Worlds.” Hideous creatures with multi-legged covered torsos with shiny black exteriors and serrated mandibles that would crunch at anyt

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

hing in their path. It was a veritable army that I watched in horror as it moved at will toward all that I held near and dear. They must have been in the thousands, no, make that the millions

; 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 stretched almost to the horizon in their relentless march of death and destruction.

I had done what I could to deter the plague. I set up innumerable barriers and obstacles, but they

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

must have laughed in their alien communication at my feeble attempts. I stood helpless as one by one, my various defenses failed to prevent the onslaught. From sprays to swatting to using a v

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

cuum, I tried everything at my disposal, but to no avail. The trek continued unabated. I stared as the swarm engulfed my kitchen floor, then entered the living room as the feasting commenced.

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

Combination pro

Any slightest crumb or morsel was devoured without the slightest slowing. I was now hiding in my bedroom, sitting on the bed with the Yellow Pages open to “Pest Control.”

The first thing th

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

at I noticed was the lead headline in most ads began with “Termites.” That would not serve my purpose. Where were the “Ant” people when you needed them? Then they talked about “Home Inspectio

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

s,” or “Family-Owned” or “Expert Service” or finally, “Free-Estimates.” Now I ask you, how would any of that solve my problem? I had Armageddon in my household and these businesses were talki

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

ng about how the family runs the place. Great. My goose was cooked. I might as well let the critters have the darn house and move outside into a tent.

I was lying on my bed filled with self-

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

pity when a shadow played on the ceiling. I sat up to see a rectangular object in front of the window. It was a large Yellow Pages standing on skinny legs and it spoke to me. “Don’t give up t

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

e old homestead just yet,” it began. “Take a look at this.” With that, he or “it,” opened up to reveal a full-page ad. The headline read, “Any and All Pests Eliminated the Same Day or Your Mo

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

Following aspects would a

ney Back.”

You didn’t need to be a mind reader to figure out what I did next. I grabbed the phone and dialed the number. Someone would be out with three hours to begin the eradication. I was

dd to the challenges in developing combination products:

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

a happy guy. When I turned to thank the character, I only saw a card on the dresser. It read, “Glad I could help. Wolley Segap to the rescue.” The end… or is it?

This little story was desig

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

ned to serve a purpose and illustrate the need for effective advertising. So, attention business people: Is your Yellow Page ad doing its job? If not, let this serve as your wake-up call. I’v

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

witnessed many companies that thought they had an ad that worked, while, in reality, it had a flawed headline, lousy copy, or pathetic artwork. How do I know?

I was a YP rep and consultant

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

for nearly 25 years and, prior to that, had my own advertising agency. I also have a degree in marketing. I’ve been designing Yellow Page ads for the past three decades. So I have expertise

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

Professional from academic institutions, pharmaceutical industries, health care indust

in YP creation and have advised almost 7000 companies on how to put together the most effective YP ads. If you have a display or in-column ad, regardless of size, color or position, I can tel

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

you it most probably needs improvement in the headline, artwork, body text, placement, book, or heading. You must understand the ROI or return on investment and learn how to track the resul

.

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

ts as well.

So consider getting some expert advice before you place your next ad. There are many good and inexpensive places to turn, some available on the internet. Make sure the consultant

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

Companies that provide selfless information through particip

is well qualified with at least 25 years experience. Otherwise, you’ll be wasting your own time and money. Then, hopefully, you wont’ really need Wolley Segap coming to the rescue after all

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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