Actual - Legal

The stage: A million-dollar condo in one of the top pre-construction developments

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

in South Florida, a high-rise oceanfront luxury building on a prime Beach locati

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

Examples of combination products may in

on.

The complaint: Buyer signed a contract and paid the deposit. A few months la

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

ter and well before scheduled completion, he is given notice of certain modificat

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

ons to the building. The most significant was about the private elevator to his u

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

Combination pro

nit. The developer is now announcing that the private elevator will be shared be

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

tween two apartments.

Other changes imply reduction of certain amenities areas.

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

The buyer wants to cancel the contract and get his deposit back alleging that th

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

changes will substantially decrease the value of his condominium unit in this ul

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

tra-luxury building.

The developer does not agree, stating that the proposed cha

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

nges are not material or substantial and would therefore be allowed by the contra

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

Following aspects would a

ct. It is not refunding the buyer’s large deposit.

Two years ago, it wouldn’t ev

dd to the challenges in developing combination products:

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

n have been an issue. The buyer would reluctantly agree to the changes since his

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

contract would have meant a couple of hundred thousand dollars profit by just “fl

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

ipping” it to one of the dozens of eager investors on a waiting list.

But this i

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

s 2006 and things have changed a lot. Developers cannot find that waiting list

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

Professional from academic institutions, pharmaceutical industries, health care indust

nymore and investors are leery of the market’s future.

The case is in its initia

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

l phase.

It is not a really unusual situation and I wouldn’t have pointed it out

.

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

but because it is illustrative enough of how the market has changed.

What is yo

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

Companies that provide selfless information through particip

ur opinion and what is your prediction of the outcome? I would value your input..

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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