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Social networking website Xanga.com was fined $1 million for violating the Children’s Online Privacy Act. Xanga was allowing members, under the age of 13, to re

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

gister online for a portfolio without their parent’s consent, the FTC – Federal Trade Commission announced Thursday.

This fine is the largest penalty ever issue

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

Examples of combination products may in

for violators of the Children’s Online Privacy Protection Act. Xanga, rival website 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.

space.com/" target="_blank">MySpace.com, allegedly permitted 1.7 million members to register for an account and specify their birthday, indicating they were

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

under the age of 13. Collecting personal information from anyone under 13 without parental consent is a violation of the children's protection act, or COPPA, wh

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

Combination pro

ch was passed by Congress in 1998.

"Protecting kids' privacy online is a top priority for America's parents, and for the FTC," FTC Chairman Deborah Platt Majora

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

s said in a statement. "COPPA requires all commercial Web sites, including operators of social networking sit

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 like Xanga, to give parents notice and obtain their consent before collecting personal information from kids they know are under 13. A million-dollar penalty s

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

hould make that obligation crystal clear."

The rise in these social networking sites, such as MySpace and Xanga, has led to a new set of Internet troubles. As

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

agree these sites are fun and have a lot of benefits, I feel the companies need to be more aware of what is happening and must implement security measures immed

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

iately to avoid issues like this in the future. It’s a serious matter and I feel very strongly about this problem. MySpace has led to numerous cases of sexual

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

Following aspects would a

predators, leading off with Nathan Contos, a 27-year-old paramedic who pleaded no contest to charges he molested a 14-year-old girl he met on MySpace.

In reacti

dd to the challenges in developing combination products:

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

n to this issue, MySpace supposedly changed their system so adults could not contact children under the age of 14. This, however, could easily be bypassed when

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

a user enters a birthday that states they are over the age of 14.

In a statement e-mailed to reporters, Xanga CEO John Hiler said the company has addressed the

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

lleged violations and added additional safeguards to prevent underage children from registering on the site. "Xanga has long been committed to making its site sa

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

fer for its members," it said. "When these issues came to our attention, we instituted a stronger, more comprehensive safety and compliance program."

According

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

Professional from academic institutions, pharmaceutical industries, health care indust

o Xanga, they have changed their technology to screen for appropriate birthdays, Engle said, and has enhanced other mechanisms designed to keep young children of

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

f the site. Let’s hope that these companies continue to implement additional security measures and consistently monitor their websites to help eliminate trouble

.

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

like this in the feature.

Our children are our pride and joy, so let’s protect them to the fullest. As the Internet continues to grow at an increasing rate th

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

Companies that provide selfless information through particip

ere are more predators, terrorists, and criminals online than every before. Let’s all try our best to create an Internet that is a safe environment for everyone

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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