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Boats in Marinas often leak a little and whatever leaks ends up in the water. When walking on the 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

ocks at the Marina you will notice the shiny stuff on the water; this is pollution and should obvio

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

Examples of combination products may in

usly not be there. We must be careful not to hurt the local surrounding sea life, birds and fish, b

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

ecause they are all part of the eco-system and food chain. If we eat fish, which feed on polluted 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

aters and other creatures, which have taken in this pollution, we too are affected in a negative wa

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

Combination pro

y.

The environment is proving to be quite resilient indeed. Yet, we want to enjoy our Lakes, river

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

s and oceans since it is a place for boaters, fishing and fun. It is a shame to see our water so of

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

ten in such disrepair after we have accidentally released sewage, chemicals or small oil spills int

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

o it. I would therefore like to propose that we coat the pillars holding these Marina Docks with a

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

special coating, which will clean as they support the structure. We have modern coatings and enviro

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

nmental dispensers, which can do this. Timed released bio-eating bacteria which feasts on oil and f

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

Following aspects would a

uel might be a worthy idea.

I propose putting small boxes near on the dock near each slip, which w

dd to the challenges in developing combination products:

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

ould release encapsulated timed pellets. These pellets would be made of spongy material, which woul

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

d not hurt the boat hulls of vessels, which might bump into them as they float. The spongy material

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

would also be made very distasteful to birds, fish, sea life and wildlife; yet would clean the loc

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

al waters and eat the oil and gas spills. If there were no spills these small sponges would not rel

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

Professional from academic institutions, pharmaceutical industries, health care indust

ease their coating material and would remain inert. The same coating on the sponges would be on the

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

pillars of the dock. Timed released biological and environmental remediation is nothing new, many

.

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

environmental engineers use this to help reduce large algae blooms which threaten drinking water su

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

Companies that provide selfless information through particip

pplies, affect water quality or are a danger to sea life. Think on this, we can solve this problem.

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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