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The press has recently focused attention yet again on New Orleans and the process of rebuilding. But this debate now entering its second year is

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

more monologue than dialogue. The emphasis has been on rebuilding and rehabilitating and not on true recovery.

A mere question of semantics? No

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

Examples of combination products may in

t really.

The dictionary defines “rehabilitation” as to restore to original condition. “Rebuild” is defined as to build again.

I for one do not

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

wish to see the Ninth Ward put back in the vulnerable condition which led to the catastrophe that was Katrina. My observation of the political co

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

mmentaries and emotional pleas that have surrounded the reclaiming of New Orleans convinces me that the residents of New Orleans also expect far m

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

Combination pro

re from those charged with its recovery.

The job of Disaster Recovery more than rebuilding, more than making whole again. The job of Disaster Rec

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

overy is to make better and create those situations and systems that prevent the next catastrophe. Disaster Recovery in the Ninth Wade will requi

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

re a novel and innovative approach. Let me suggest one such solution.

Here in Florida we have a unique device, an odd machine called a Dirt Buil

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

ing Plant. This natural gas fired device is used to literally burn contaminated dirt until it is clean. The machine is basically a large inciner

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

ator which safely burns off hazardous materials, petroleum contaminants, organic contaminants and other items found in the soil.

I propose that s

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

veral of these devices be moved into the areas of Ninth Ward where the homes can no longer be repaired or reclaimed. The entire area be cleared a

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

Following aspects would a

nd placed through the dirt burning plants. Additional fill soil would be brought from the various “hazmat” landfills, placed through the dirt bur

dd to the challenges in developing combination products:

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

n process and added to the Ninth Ward elevating it until finally the surface of the Ninth Ward is level with the top of the levies. This will eff

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

ctively reinforce the earthen levies changing them from levies to new river banks. The Ninth Ward would become valuble riverfront property.

The

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

land would then be returned to the people of the Ninth Ward. They would have the option of rebuilding their homes on new high ground, above the l

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

vel of future flooding. They could set strong foundations deep into the earth and in compliance with the newest building codes. Alternatively re

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

Professional from academic institutions, pharmaceutical industries, health care indust

sidents choosing not to move back to the Ninth Ward could sell their land now far more valuable because it is both high ground and riverfront prop

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

erty. The development would revitalize the New Orleans economy and the new homes would revitalize the Ninth Ward.

Certainly there would be obsta

.

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

les, the emotional impact of burning and burying the old Ninth Ward will be hard for many to swallow. But like a phoenix rising from its own ashe

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

Companies that provide selfless information through particip

s the Ninth Ward would be resurrected not as an example of society failing its most vulnerable members, but as an example of serving those in need

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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