Actual - Real Estate

I must first start this by telling you that I am a resident of Mauldin. I always have been. I have l

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

ived on the same street since I was born. In fact, I bought a house just two doors down from where I

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

Examples of combination products may in

rew up. So when I see us moving in the right direction, it makes me pretty happy.

The Mauldin City C

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

ouncil met on February 8 to have what they call a goal setting workshop. This workshop only lasts abo

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

t an hour, and the purpose is to talk about short and long-term goals for the city of Mauldin. Think

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

Combination pro

f this goal setting meeting as leading by committee. The City Council will get together and vote on a

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

nd discuss the most popular ideas that come out during the brainstorming session. Less popular ideas

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

re ranked lower and get less discussion.

New Signs One of the things that was discussed at a city Co

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

uncil meeting was the need for new entrance signs for Mauldin. I believe that this would be a good id

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

a, as the current entrance signs to Mauldin are both a) small and b) not very good looking.

Biking Tr

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

ils As a biker myself, I of course would like to see Mauldin develop some bikeways. The idea of the

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

Following aspects would a

city Council is to improve traffic flow and link all the sidewalks in the city together. This would b

dd to the challenges in developing combination products:

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

interesting to see. I don't see there being any significant improvements for bikers by doing that, b

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

ut who knows.

New Post Office I have to agree with this proposal by Councilman Dale Black more than

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

ny other idea that was thrown out. Mauldin definitely needs a new post office. If you have ever had

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

o wait in line at the Mauldin post office for more than 30 minutes, you are not alone. Anyone who is

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

Professional from academic institutions, pharmaceutical industries, health care indust

trying to run a business in Mauldin that involves sending mail, which would be most businesses, is so

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

rustrated by the Mauldin post office that they end up driving to other cities. This has got to stop!

.

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

In sum, Mauldin is trying to move in the right direction. It is good to see that at least this commu

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

Companies that provide selfless information through particip

ity is proactive in our city council is trying to think of creative ideas to keep our city competitive

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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