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The U.S. housing market is still in trouble, due mainly to failed subprime mortgage prac

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

tices. Recent home sales reports show a modest increase, however the increase is conside

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

Examples of combination products may in

ed by many analysts to be half of what they were expecting.

Analysts believe the major

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

contributor to the housing slump is the increase in mortgage foreclosures, or more speci

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

ically subprime mortgage foreclosures.

Over the past several years, many subprime home

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

Combination pro

ortgage institutions were offering home mortgages to individuals who should never have r

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

eceived them. The homeowners receiving them did not meet traditional basic financial hom

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

mortgage standards. However, as with any sector boom, there are always folks out there

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

ooking for a quick buck. Unfortunately, in this case it was fly-by night home lending in

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

stitutions that quickly setup shop and took advantage of the housing market boom. Normal

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

y good lending institutions cap the amount a homeowner can finance, relative to their in

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

Following aspects would a

ome. This cap usually has been in the range of 28-33% of their income for the home morta

dd to the challenges in developing combination products:

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

ge, and around 36% for total financing including; home, car, credit card purchases, etc.

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

These fly-by night home lending institutions allowed much higher caps, basically enslavi

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

g the homeowner to a home mortgage that they could not sustain. The result, eventual for

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

eclosure.

The housing market has now taken a hit by this type of lending behaviour and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ompanies such as Lowes and Home Depot have already seen an impact in their businesses.

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

he speed in which the home industry turns around will be directly proportional to how qu

.

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

ickly the subprime mortgage industry gets cleaned up. Fortunately the cleanup has alread

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

Companies that provide selfless information through particip

begun, however there is probably another year ahead of us before the smoke fully clears

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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