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One year ago Hurricane Katrina devastated several southern states and created co

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

mplete and total devastation to thousands of people. Many were completely displa

; 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 and forced from their homes. In all senses, the people that were directly hi

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

t by Katrina’s wrath lost everything they owned. Homes, businesses and schools w

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

re completely and utterly gone. Many people had nowhere to go and were in dire

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

Combination pro

need of assistance.

When a natural disaster strikes with the magnitude of power

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

such as Hurricane Katrina, many are left to wonder how they will ever go back to

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

a normal life. It is hard to imagine losing everything but many people did in f

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

ct lose everything they owned. Children could not attend school because of cours

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

e the school was completely devastated by wind and water.

Our Federal Emergency

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

Management System has done their best to help the people affected by Katrina but

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

Following aspects would a

in most cases it just wasn’t enough. Business owners were forced to either rebu

dd to the challenges in developing combination products:

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

ld or close their business, affecting their entire livelihood and causing grief

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

to many. Although it has been a year since Katrina unleashed her fury, many busi

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

ess and homeowners turned to the government for assistance.

The government offe

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

red businesses and homeowners that wanted to rebuild, low interest loans to basi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ally jump-start their lives. Many found the low interest loans a great comfort a

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

s they tried to rebuild what they have lost. Although a low interest loan cannot

.

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

bring back their lives, it enabled people to have hope and the courage to rebuil

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

Companies that provide selfless information through particip

d their homes, businesses, and in all senses of reality, their dignity and lives

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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