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When my daughter was suddenly killed in a car crash I was overcome with grief. She was 45 years old, finally at a secure place in life, excited abou

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

t her children and her job. My father-in-law died on the same weekend and, though we expected his death, it was still a shock. I am co-executor 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

y daughter's estate.

While I am glad she had a will, her finances are a mystery. My husband and I have become financial detectives, tracking down l

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

ads and trying to make sense of them. Grief and Probate are a heavy burden, a burden filled with questions. We must answer these questions and more

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

What bank did she use? Did she have a safe deposit box? How much cash does she have? What bills are outstanding? Did she invest in stocks or bo

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

Combination pro

nds? Did she take out any loans? Does she owe money on her two cars? Is she still owed salary? If so, can we deposit her salary? What benefits i

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

she entitled to? What is the homestead value of her house? What is the market value of her house? How much is her personal property worth? Did s

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

e pay her federal and state taxes?

These questions add up to a financial nightmare and we are already living a grief nightmare. You can avoid simil

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

r circumstances by doing your financial homework. What does this homework involve?

REVIEW YOUR WILL. Laws may have changed and you may have to cha

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

nge the wording of your will, or as in our case, the executor.

HIRE A LAWYER. We need two lawyers, one to help us with our daughter's will and Prob

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

te, and another to help us with her home and personal property.

PUT FINANCIAL INFO IN WRITING. Write down the name of your bank, your account numbe

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

Following aspects would a

(s), and the number of your safe deposit box if you have one. Give this list to someone you trust.

RECORD INVESTMENTS. You may keep this record yo

dd to the challenges in developing combination products:

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

rself, or ask your stock broker or financial advisor to do it. The important thing is to have written proof of your investments.

APPRAISE YOUR HOME

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

. Ask a professional appraiser to determine the current value of your home and photocopy the appraisal. Put one copy in your safe deposit box and g

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

ve the other to a trusted relative.

PHOTOGRAPH POSSESSIONS. These photos are legal proof of ownership. Pay attention to detail when you take the p

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

otos. For example, if you collect rare books photograph the covers. Put the electronic chip or actual photos in your safe deposit box.

INVENTORY Y

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

Professional from academic institutions, pharmaceutical industries, health care indust

UR HOME. I have just started this process and am going to buy a software program to help me with the inventory.

PUT SPECIAL BEQUESTS IN WRITING. T

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

hese bequests may include family heirlooms, art work, special collections, and specific items, such as a boat. Tell relatives/friends about your int

.

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

ntions. Again, put this list in your safe deposit box.

In case you are wondering, I am taking my own advice, for I do not want my remaining daughte

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

Companies that provide selfless information through particip

or grandchildren to have the same financial nightmare. Doing your financial homework is a gift to those you love.

Copyright 2007 by Harriet Hodgso

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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