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In 1859, miners around Mt. Davidson, Nevada were panning and slucing 1

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

8 hours a day for enough gold to pay for grub and drinks. They were ha

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

Examples of combination products may in

mpered in their mining by blue clay. The blue stuff clogged their equi

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

pment, interferred with their efforts and made mining for gold darn n

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

ar impossible.

Finally, one man had the dreaded, awful, ugly, blue st

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

Combination pro

uff assayed. To his surprise the results estimated the blue stuff's wo

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

rth at $3,000 a ton! The blue clay was extremely rich silver ore.

New

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

spread fast and speculators headed to Nevada. One miner didn't get th

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

e news soon enough. He sold his claim for $450 and ran through the str

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

eets laughing and proclaiming that he had tricked the Californians.

H

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

ended out his career as a peanut vendor.

The person who bought his cl

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

Following aspects would a

aim became one of the wealthiest men in the world.

It's too bad that

dd to the challenges in developing combination products:

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

the poor goober hadn't heard of market research. If he had thought abo

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

ut his complaints, done some brainstorming, searched for product info

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

mation, or even just conducted a simple survey -- he may have seen oth

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

er options and opporunities. Had he done just the tiniest bit of mark

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

Professional from academic institutions, pharmaceutical industries, health care indust

et research, he might have owned the richest silver deposit on Earth i

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

stead of settling for peanuts.

Market research can be done simply and

.

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

effectively and the results can save money and effort. Almost anyone

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

Companies that provide selfless information through particip

can conduct their own research projects . . . and find a silver lining

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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