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It's funny , I have been in the water damage restoration industry for over 20 ye

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

ars. Yet every time I answer a call from a customer who has a water damage it's

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

Examples of combination products may in

amazing that the same issues and questions are still asked. Here are a sample of

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

some of the questions I have been asked and the answers that I know will help y

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

ou in a tight situation.

Here is a story that happened many years ago. I re

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

Combination pro

ceived a call a couple of years ago from a man that said he had a sewage damage

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

in his basement. It seems that the sewage line backed up into his basement and h

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 had about two inches of sewage. I told him about our service and he said that

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

he was only looking for advise. I then explained what he should do to clean and

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

"correctly" disenfect his basement. Part of the cleaning process is to wear pu

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

ncture resistant boots and rubber gloves. I explained that sewage can contain a

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

Following aspects would a

ll types of diseases and dangerous microbes that could harm his health.

He stop

dd to the challenges in developing combination products:

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

ped me there to explain that wearing protective clothing would not be necessary

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

due to the fact that the sewage in his basement was his family not any one elses

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

. Shocked at that statement I explained to him that in sewage systems that back,

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

normally involve the county sewer system. This as you can imagine has everybod

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

Professional from academic institutions, pharmaceutical industries, health care indust

y's waste now in your basement. He was now sharing everybodies disesases, micro

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

bes, aids microbes, hepetitas,( the list goes on).

I then heard a silence and I

.

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

asked if he was still on the phone. He started to speak very low and asked if t

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

Companies that provide selfless information through particip

hey should go to the hospital to be checked out. I said it would be a good idea.

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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