Answers - Real Estate

Good communication between you and your contractor is the best way to ensure that your project runs smo

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

othly without any glitches. How much communication is enough? Well, in most cases you cant communicate

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

Examples of combination products may in

oo often. More communication is always better than less. Communication And since there is something new

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

happening on your project more or less every day, a good rule of thumb is to check in with your contra

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

tor once per day.

Now, chances are both you and your contractor are very busy, and even with the best

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

Combination pro

of intentions it is going to be difficult to follow through with meeting once per day. Well, thanks to

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

odern technology there is no need for a physical meeting, and daily communication couldn't be made any

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

easier. If daily meetings in person are just not possible, don' t let that stop you from checking in re

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

ularly. Use your phone or email instead. Why do you need to have a meeting every day? Well, it all is g

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

oing smoothly you'll know it and will have peace of mine. But if issues or problems arise—and they will

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

you'll have a better chance of nipping them in the bud.

Communication

It's a very good idea to come u

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

Following aspects would a

p with a list of questions that you would like answered in your daily update. Make your contractor awar

dd to the challenges in developing combination products:

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

of these questions, so that he knows what to expect. Ask the same questions every day, and your update

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

s, if all is going well, shouldn't take more than a few minutes. Some questions you want to ask might i

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

clude:

• What did you work on today?

• Are you still on schedule and on budget?

• Did any problems,

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

issues, or concerns arise today regarding the project?

• What are you working on tomorrow?

• Is there

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

Professional from academic institutions, pharmaceutical industries, health care indust

anything you need from me today to keep this project running smoothly on time and on budget?

Remember,

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

communication works both ways. If you are having any issues—say you don't like some aspect of the way

.

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

he project is going—it is important that you bring this up to your contractor as soon as possible. Comm

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

Companies that provide selfless information through particip

unication Your contractor may be building you your dream house, but that doesn't mean he can read minds

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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