Just Answers - Communications

The Facts

• Computer phones (VoIP) offer the most optimal means of communicating when considering quality

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

and cost, and can save businesses up to 80% on their phone bills when calling from PC to PC, to landlines,

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

Examples of combination products may in

or to mobile phones, regardless of company size.

• Over 90% of all VoIP solutions providers operate on uns

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

ecure lines or platforms, whether free or charging for services.

• Greater than 95% of all VoIP solutions

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

roviders do not have their own patented technology

General Information

• Calls placed on unsecure lines t

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

Combination pro

ravel from one computer (IP address) over the internet to another computer (IP address) have little or no p

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

rotection in between calls to guard against terminal viruses, Trojan horses, unscrupulous hackers, or uninv

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

ted guests listening in on private conversations.

These unsecure lines leave users dangerously vulnerable

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

to the inevitable and expensive computer crash that forebodingly looms over the horizon.

• Calls placed on

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

secure lines go through a VoIP platform (server) that incorporates its own security (including patented te

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

hnology) against the ills of unsecure lines, thereby offering maximum security, privacy, and peace of mind

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

Following aspects would a

for its users.

• Note: higher enrollment and monthly fees, or well known phone companies now offering VoI

dd to the challenges in developing combination products:

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

P services do not necessarily automatically guarantee security.

Recommendations

• Contact your VoIP solut

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

ions provider (if applicable) and request written information regarding security of their service, along wi

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

h patented technology they own. Ask if their service hosts embedded spyware on lines and/or allows public

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

access to names and numbers of subscribers.

If the requested assurances cannot be produced, take immediate

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

Professional from academic institutions, pharmaceutical industries, health care indust

action to avoid playing Russian Roulette with your business.

• Protect the security of your company’s com

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

unications and privacy, while simultaneously experiencing exponential savings on phone bills, by locating a

.

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

nd subscribing to a VoIP solutions provider who offers a secure platform that incorporates its own patented

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

Companies that provide selfless information through particip

technology.

• Analyze your computer’s security for free by going to http://www.Symantec.com/SecurityCheck

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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