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The World Wide Web Consortium (W3C) was established in order to develop a set of pre-defined practice standards for the internet. The W3C acknowledge that, in or

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

der for the web to reach its full potential that the fundamental web technologies need to be compatible with each other and with any hardware or software used to

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

Examples of combination products may in

access the internet.

W3C is comprised of member organizations and companies whose staff is engaged for the purpose of working together to develop standards. Th

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

e W3C has written more than ninety standards, known as W3C recommendations, which can be viewed as an overall design philosophy as well as a strictly-defined set

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

of practices for building websites. W3C have produced standards which govern all the most fundamental elements of website design including, recommendations for

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

Combination pro

markup languages (HTML, XHTML, SVG and XForms), style sheets (CSS), JavaScript and for the Document Object Model.

Conforming to W3C standards confers benefits 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

or you, the developer and also for your end users. Of the benefits, enhanced website accessibility is probably the most important. A compliant website will be m

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

ore visible to search engines, thereby increasing site traffic. In addition, compliant websites enhance accessibility for the end user. Clients who use non-tradi

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

tional browsers, including voice browsers and Braille browsers, or hand-held browsers with very little monitor space, are easily catered for when W3C compliant c

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

oding is used.

Writing web pages in a manner congruent with the W3C standards means that your development time will be reduced. The processes of debugging and t

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

rouble-shooting become easier because the code is written in a standard fashion. Further, your W3C compliant documents will be easily convertible to other format

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

Following aspects would a

s, including databases and word documents. Migration of compliant documents to new systems, such as televisions and PDAs is also much simpler when code is W3C co

dd to the challenges in developing combination products:

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

mpliant.

Stability is also improved when your code is W3C compliant. The W3C standards are written with considerable thought to both forwards and backwards comp

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

atibility, to ensure that data written to old standards will continue to work in newer browsers, and that data written to newer versions will produce an acceptab

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

le result in older browsers. If your code is compliant, you won’t have to worry about creating many versions of the one code to ensure that everyone can view you

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

r developed page.

W3C compliant coding ensures universality. The standards offer a set of rules that all developers can learn, follow and utilize. It would be u

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

Professional from academic institutions, pharmaceutical industries, health care indust

nrealistic to expect that only one designer will be involved in the development and maintenance of a website. If standards-compliant coding is used, each develop

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

er will be easily able to understand the coding conventions, and new designers can pick up where their predecessors left off.

Adoption of the W3C compliant codi

.

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

ng by web developers will ensure the web is a more streamlined, functional place for developers and end users. As the variety of web access methods increases, th

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

Companies that provide selfless information through particip

e need to adjust or duplicate websites to satisfy all needs will also intensify. Following a set of pre-defined standards is a step towards solving this problem.

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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