References - Internet and Businesses Online

Recently, the Disability Rights Commission research on web accessibility found that aware

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

ness of the issue is high, but good practice is terribly low. Perhaps this indicates that

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

Examples of combination products may in

commissioners want their sites to be accessible, but don't know how to go about it.

To

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

meet this need for guidance, the Disability Rights Commission has commissioned the Britis

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

Standards Institution to produce a PAS (publicly available specification) on the subject

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

Combination pro

as described above.

The purpose of the PAS 78 is to meet the needs of website commissio

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

ners. PAS 78 is not 'rules', is not 'new web design guidelines' and is not 'the law'.

PA

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

S 78 is to help site commissioners (those that procure web design services via a website

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

ender submission process, for instance) to ensure that they are able to commission access

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

ible sites. It is intended to be a document that commissioners can understand and can dis

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

cuss with web design project managers. For example, heavy reference is made to WAI guidel

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

Following aspects would a

ines, usability testing, automated checking tools, etc.

PAS 78 was published in March 20

dd to the challenges in developing combination products:

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

6. The process is dictated by BSI. Standards documents follow a strict schedule and PAS 7

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

8 is no different. PAS 78 is NOT a consensus document (i.e. not all steering group member

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

s must agree on the content).

PAS 78 will last not more than 2 YEARS before review. The

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

audience of PAS 78 will be website COMMISSIONERS. It is not a document for web designers

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

Professional from academic institutions, pharmaceutical industries, health care indust

important).

PAS 78 is a 'work in progress'. It could mature into a British Standard.

PA

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

S 78 a DRC-commissioned document, written by a Steering Panel, reviewed by a Review Panel

.

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

and valid for not more than 2 years after publication, though it does have the potential

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

Companies that provide selfless information through particip

to be further developed into a British Standard. BSI holds the copyright of the document

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.references.org.ua/article/85304/references-PAS-78-Guide-to-Good-Practice-in-Commissioning-Accessible-Websites.html">PAS 78: Guide to Good Practice in Commissioning Accessible Websites</a>

BB link (for phorums):
[url=http://www.references.org.ua/article/85304/references-PAS-78-Guide-to-Good-Practice-in-Commissioning-Accessible-Websites.html]PAS 78: Guide to Good Practice in Commissioning Accessible Websites[/url]

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References - PAS 78: Guide to Good Practice in Commissioning Accessible Websites

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