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In 2005, a group of leading certification authorities (CAs) and Internet browsers came together to establish a more rigorous and harmonized approach to online SSL security.

Known as the CA/Browser Forum, the group decided a standardized Secure Socket L

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

ayer (SSL) method was needed, to prove a website’s authenticity across all browsers, for all CAs and for all Web users. In January 2007, new Extended Validation (EV) SSL certificates were at last released worldwide, and are expected to greatly enhance e

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

Examples of combination products may in

Commerce and boost the confidence of online shoppers everywhere.

Wayne Thayer, Vice President of Development for GoDaddy – a world leading SSL Web hosting provider, domain registrar and major member of the CA/Browser Forum – told TopHosts that the aim

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

of EV SSL is to provide a much needed, unvarying way of ensuring legitimacy online.

“There were a number of major players that felt we needed to create some sort of standard we could bring to the marketplace,” Thayer said. “A certificate that meant the

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

same thing no matter where you bought it from.”

Up until the launch of EV SSL, Thayer explained many differing levels of SSL certificates could be obtained, but none really going beyond WebTrust – a seal awarded to sites that adhere to certain business

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

Combination pro

standards. Many different types of SSLs, like GoDaddy’s Turbo SSL and High-Assurance SSL, for example, provide great protection and online assurance, but may not abide by the same rules and regulations of other CAs and Web hosting providers. There is s

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

imply no uniformity among them, and they don’t address growing concerns regarding phishing, a form of Internet fraud that aims to steal valuable information such as credit cards, SSNs, IDs and passwords, through fake websites.

With EV SSLs, all CAs mus

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

adhere to the same security standards when processing certificate requests, while visitors to EV SSL-secured sites can trust that the online organization has undergone the same universal authentication process.

“The EV vetting process creates a very s

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

trong tie between the organization that is named in the certificate and the actual real world organization,” Thayer said. “… EV SSL has a number of additional steps that make it much more difficult for fraudsters to perform phishing and pretend they’re

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

something they’re not.”

The CA/Browser forum outlines a new EV SSL vetting process, which validates elements such as, the legal existence of the site, the legal name of the entity, a registration number, right to use the domain name, along with other l

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

gal indications. To apply for an EV SSL, the business must present a letter from an attorney or an accountant. The process verifies the organization’s identity, the validity of the request and the overall legitimacy of the business.

Unlike the standard

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

Following aspects would a

padlock icon method used for all other SSL certificates, browsers with EV support will display a green address bar and a special label, which names the website owner and the CA that issued their certificate. This visual tool is especially useful for do

dd to the challenges in developing combination products:

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

mains considered to be a high-risk target of phishing and other fraud schemes. Banking sites, auction sites, retailers and other financial services can better communicate their legitimacy to users, allowing visitors to confirm that any online informatio

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

n they volunteer is safe and protected by EV.

Currently, only Internet Explorer 7 and Opera 8 browsers are EV-ready and support the new visual indicators. Mozilla and Safari are known to be committed to supporting the concept of EV, with Firefox expect

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

d to implement it in their version-3 release.

So far, Thayer says adoption of EV SSL has been slow, but exactly what was expected. Larger eCommerce sites are taking to it more quickly, as they recognize its potential for combating phishing. But it migh

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

t take longer for it to take off within the smaller business community.

Currently, the standard requires companies to be incorporated to qualify for EV, which severely limits adoption by smaller entities wanting the universal assurance EV SSLs offer. T

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

Professional from academic institutions, pharmaceutical industries, health care indust

hayer explained the difficulty behind implementation of EV SSL with smaller businesses, as they don’t maintain the same official documentation corporations do.

Instead, smaller businesses identify themselves through mainly state-level and local files,

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

aking it harder to apply them to the universal EV SSL approach. But Thayer says GoDaddy and the CA/Browser forum are working to establish EV SSL security for the smaller business community, in the near future.

Yet, as IE 7 becomes more widespread and 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

s more SSL certificates begin to expire, companies will likely consider the advantages of EV and take on the new certificates.

“I think as you see Internet Explorer 7 gain more traction and as more begin to see and recognize the green address bar, we’l

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

Companies that provide selfless information through particip

l see more adoption of these certificates,” Thayer said. “It’s too early to tell right now, it’s only been a couple of months, so if most SSLs expire within a couple of years of issuance… we’ll see a majority of sites rolling over to EV by January 2009.

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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