Actual - Finance

About eighteen months ago, my husband and I made a decision to take the advice of financial counselor D

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

ave Ramsey and get out of debt. Although we hit a number of snags which resulted in us taking a year of

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

Examples of combination products may in

(little things, like unemployment and a new baby), we were grateful to have listened to Dave in our st

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

ruggles. Furthermore, now that we are back to paying off our consumer debt, we are fired up and wired u

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

!

I started listening to Dave Ramsey in December 2005, when an online friend recommended him in answer

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

Combination pro

to some financial questions I had. Like most young American couples, my husband and I were struggling w

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

ith “too much month at the end of the money.” We tallied up our total debt and were shocked. We decided

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

to sit down and get busy getting rid of it.

I’m the nerd; my husband is the free spirit. At first, whi

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

le he was in agreement to get out of debt, he wasn’t as “gazelle intense” as Dave recommends. I quickly

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

changed that. I took a dry erase marker and wrote down the balances on our credit cards on our bathroom

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

mirror. Each time we made a payment to one, I changed the number. This provided a two-fold result: I go

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

Following aspects would a

t excited to pay the bills for a change, and he was constantly reminded of the total debt we owed. This

dd to the challenges in developing combination products:

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

helped tone down his spending, and I am convinced it is a big part of how he went from unexcited to gaz

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

elle intense.

The hardest part for us has been taking a year off and losing momentum. While we struggl

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

d with unemployment, things seemed to grow bleaker. However, had we not been on Dave’s plan already, 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

now we would have gone even deeper into debt, digging a worse hole for ourselves. I’m grateful for the

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

Professional from academic institutions, pharmaceutical industries, health care indust

encouragement from Dave to keep us on track even amidst our struggles.

We are planning to be debt free

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

by Christmas of 2007. We will call Dave on the day before our 7th wedding anniversary (which falls on a

.

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

Saturday) to scream “We’re debt free!” My kids are already primed. I hear myself yelling over and over

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

Companies that provide selfless information through particip

again. The joy that I know I will feel at that moment makes all of the hard work and sacrifice worth it

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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