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Have you ever had a credit card stolen? Have you ever had your wallet stolen? Have you

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

ever had your identity stolen? Do you feel if you mailbox is safe if unlocked? If you

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

Examples of combination products may in

have answered yes or no to any of the questions, read on.

I lived in an apartment com

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

lex where the mail boxes were locked. I felt relieved and stress free. I did not have

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

o worry about some strange person stealing my mail in the dead of night.

Now I live i

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

Combination pro

a complex where the mail boxes are not locked. If I want a locked mailbox I have to p

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

y for the privilege at my local Post Office.

With identity theft on the rampage what

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

appened to the corner mail box? We have so few choices in our mail system. Either use

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

mail slot that opens directly into your home or garage or use your unlocked mailbox.

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

I want to know this, WHAT HAPPENED TO ALL THE CORNER MAIL BOXES? Those were the safest

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

I walked across the street to use by corner mail box. Guess what it wasn’t there! I k

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

Following aspects would a

now that the post office has to save money but identity theft is obtained from somebod

dd to the challenges in developing combination products:

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

stealing mail from your mailbox.

Instead of the post office removing the corner mail

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

boxes we need more. We have to have someway we can feel that our mail is safe arriving

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

and leaving. The Federal Post Office is not on every corner, therefore, not convenient

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

for everyone.

If we can put a lock on our own private mail boxes do it! If you can ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

e a mail slit directly into your home or garage do it! But there are many of us with w

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

ich this is not an option. Then get a P.O. Box at your local post office. We must prot

.

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

ct ourselves and our families.

Thank for reading my article. Please feel free to read

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

Companies that provide selfless information through particip

any of my other numerous articles on various subjects.

Copyright Linda E. Meckler 200

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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