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Security flaw announcements have grown into a very popular electronic sport. It is a constant race against time to become the first one to announce the latest flaws found in the most famous

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

software applications. Rival users of similar products are often in competition with each other to prove which application is the most secure. It is often a case of throwing mud at each ot

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

Examples of combination products may in

her, instead of taking the safety of other users into consideration.

Do non-technical users sign up for technical newsletters, do they read technical blogs or do they take part in technica

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

l discussions? Many of them don’t, it is in most cases only technical people discussing these matters and reading the technical newsletters. Most people are only interested in using the sof

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

tware and do not care about taking part in a forum discussion about the latest security flaw in the software. This is the point I’m trying to make, if your goal is the safety of other users

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

Combination pro

, who do you want to save when your forum post or article never reaches the audience who needs the information the most? Even if you reach the right people, what’s the use of announcing a f

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

law if you can’t provide a safe and solid solution to the problem? What do you want people to do when a severe virus is raging on the Web, a virus for which there is no fix at that specific

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

time? Do you think everyone will suddenly stop using the Internet because of your useless information? You are only giving the flaw unnecessary publicity, exposing each user of the softwar

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

e to even greater exploits.

The animated cursor flaw of Internet Explorer is a good example where there was no solid solution to the problem when it became a known threat. At least most pe

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

ople suggested that Internet Explorer users switch to Firefox, but every coin has two sides. The flaws of Internet Explorer proved once again that there is ample reason to switch to a safer

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

alternative like Firefox, but we all know how reluctant most Internet users are to switch to a new browser. Yet again, if people do not want to listen to good advice, let them burn their f

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

Following aspects would a

ingers. Unfortunately this flaw resulted in debates about which browser has the most flaws, its like arguing about whose car is the fastest if there is no road to drive it on. Switching to

dd to the challenges in developing combination products:

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

a safer browser will not disinfect a PC already infected with a virus. After all, what’s the use of having the safest browser in the world if you can’t even get it to run on an infected PC?

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

Software developers should provide proper channels through which users can report flaws and more importantly, companies should act promptly on these reports. It is because of the poor res

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

ponse from major companies, that people start to seek alternative methods, out of frustration with their hear-no-evil, see-no-evil approach. A while ago I discovered a severe flaw in a very

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

popular free anti-virus application, but the only channel through which I could discuss problems surrounding the free version, was through their online forum. This means you seldom talk to

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

Professional from academic institutions, pharmaceutical industries, health care indust

the actual developers or employees of the company, only forum moderators and members. I understand and I have experienced these frustrations, if there is no one you can talk to about a ser

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

ious problem surrounding their software, who on earth do you turn to?

There is a huge difference between the announcement of a security flaw and the announcement of a patch to fix a flaw.

.

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

If you can’t provide a proper workaround for the problem, if you are unable to tell someone who can do something about it, keep it to yourself. Announcing security flaws without contributin

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

Companies that provide selfless information through particip

g to the solution is like someone announcing the release of poisonous gas into the air and instead of handing out gasmasks, he suggests that everyone hold their breath until the gas is gone

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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