Answers - Communications

Years ago, a telephone was dialed manually and it featured a handset that we used to talk to our friends and family. While that teleph

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

one still exists today, the internet phone is changing the way people talk - literally. An internet phone is a process by which voices

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

Examples of combination products may in

are routed via the internet for, what is often, considerably less than the cost of a conventional telephone.

An internet phone can pro

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

cess incoming calls, audio and video conferences, etc. In addition, the internet phone can be used anywhere that has the capability of

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

connecting to the internet, including on a vacation. In fact, the internet phone allows individuals to travel worldwide and still be a

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

Combination pro

ble to make or receive phone calls.

Even with all of it’s benefits and the many advancements of technology, the internet phone does ha

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

e a few drawbacks. For example, quality challenges are sometimes present as there may be delays or scratches in the connection. While

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

conventional telephones are connected to reliable telephone company lines, internet phone users do not have the same advantage. Power

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

failure does not necessarily affect conventional phones, but where an internet phone uses a modem to connect calls, a power failure cou

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

ld result in the loss of a connection. The only exception may be if the individual has a notebook computer and operates his/her intern

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

t phone via battery backup on their computer.

Another drawback to the use of an internet phone is the difficulty in routing emergency

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

Following aspects would a

calls. In fact, some locations may result in an impossible connection to an emergency call center. There are plans in place, however,

dd to the challenges in developing combination products:

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

to correct the problem by implementing the technology that would allow successful emergency calls. The security of internet phone call

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

s may also be in question as the majority of calls are not supported by encryption. This makes it easier for anyone to overhear or gai

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

access to the conversation, even without permission or the knowledge of the talking parties.

As the popularity of the internet phone

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

continues to grow, the creators will continue to implement improvements that will keep their customers chatting. When the internet beg

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

Professional from academic institutions, pharmaceutical industries, health care indust

n years ago, nobody could have envisioned a day where faxes, phone calls and mail would be exchanged via the world wide web. Today, al

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

l of that has changed. Where there once was only postage fees for mail, e-mail is now free. Where there once was fax paper and toner,

.

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

there are now ways to deliver faxes directly to an e-mail box. And, where there once was dialing a phone, there is now dialing into an

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

Companies that provide selfless information through particip

internet connection and video conferencing. As the internet expands with each passing day, the internet phone is sure to grow with it

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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