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Spam, as defined in the context of computers, the Internet and electronic messaging, is a term used to designate unsolicited bulk electronic messaging and communication. In particular, spam is unsolicited bulk mailings that are commercially oriented. It is most commonly used in advertising, but it is also used to perp

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

etrate religious, political or other types of messages. Spam is, often times, considered the electronic equivalent of junk postal mail, telemarketing or broadcast faxing. Spam got its bad name and reputation from the advertisement of ill reputable and questionable products, such as pornography, pyramid schemes, fad pr

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

Examples of combination products may in

ducts, pump-and-dump stocks, etc.

Spam is delivered via several mediums, to include:

· E-mail messages

· Search engines

· Instant messaging

· Web blogs

· Usenet newsgroups

· Text messaging mobile phones

· Internet telephony

The growth of spam is a result of the cost benefit to initiators, who need only devise

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

and develop distribution lists. The other associated costs of spam, such as bandwidth, message management and loss of productivity, become the responsibility of recipients of the messages, ISPs or other public and private entities.

In 2003, the US passed the Controlling the Assault of Non-Solicited Pornography and M

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

rketing (CAN-SPAM) Act of 2003, which establishes standards for sending commercial e-mail. More specifically, the act is intended “to regulate interstate commerce by imposing limitations and penalties on the transmission of unsolicited, commercial electronic mail via the Internet”. The act establishes the Federal Tra

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

Combination pro

e Commission (FTC) as the overseer of its provisions.

The act establishes electronic mail as extremely important in communication since it “provides an opportunity for the development and growth of frictionless commerce”, which is being threatened by unsolicited commercial email. The act establishes the following as

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

criminal behaviors when used in connection with foreign or interstate electronic mail:

· Knowingly accessing a protected computer without authorization

· Intentionally deceiving or misleading the origin of messages

· Falsifying header information

· Falsifying registration information for 5 or more e-mail accounts

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

r 2 or more domain names

· Falsely representing one's self as the registrant of 5 or more IP addresses

· Obtaining e-mail addresses through improper means

· Perpetrating fraud, identity theft, child pornography, obscenity and the sexual exploitation of children.

Criminal penalties include a fine and/or imprisonmen

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

t for up to 5 years dependent upon:

· The volume of electronic transmissions

· The amount of falsified information

· Losses incurred by others

· Monetary gains from the act

· Whether the act was committed in furtherance of an felony

· Prior offenses.

Civil penalties are dependent upon the jurisdiction placing t

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

e charges and may range from hundreds of dollars to millions of dollars, dependent upon the severity of the crimes and losses involved. Also, property traceable to proceeds from monetary gains and equipment used to commit an offense may be forfeited to the US government.

As critics of the law argue, the legislation f

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

ils to dictate to marketers and advertisers, not to spam. In fact, the act does not make reference to the term, “spam”, except as used in the name, CAN-SPAM. The act makes reference to the phrase, commercial electronic mail message, and defines it to be “any electronic mail message, the primary purpose of which is the

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

Following aspects would a

commercial advertisement or promotion of a commercial product or service (including content on an Internet website operated for a commercial purpose)”.

Legislation is intended to curb practices inherent in spamming, such as e-mail harvesting, dictionary attacks and using viruses and Trojans to perpetrate messages. T

dd to the challenges in developing combination products:

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

e act establishes the following with respect to commercial electronic mail messages:

· A message must contain a legitimate return address.

· A message must include and specify a method to opt-out of receiving further messages. The ability to opt-out must be available for 30 days.

· The sender may not initiate messa

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

ges after 10 days of receipt of an opt-out.

· The sender may not sell, lease, exchange or transfer the opt-out e-mail address to an affiliate.

· The sender may offer a menu of options that allow the recipient to either opt-out or opt-in to future messages*.

· A message must include an identifier that specifies the

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

essage as an advertisement or solicitation.

· Messages containing sexually oriented material must contain clearly identifiable markings or notices

· A message must include a valid, physical, postal address by which the sender may be contacted.

· The sender may not send messages to addresses that were knowingly acqu

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

red from proprietary websites and ISPs, through automated methods. Particularly, when the site or ISP provides notice of their refusal to give, sell or transfer addresses for the purpose of initiating electronic mail messages.

· The sender may not create automated scripting and other means to gain multiple email addr

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

Professional from academic institutions, pharmaceutical industries, health care indust

esses for the purpose of transmitting illegal messages.

· The sender may not transmit messages from a computer or email address obtained without authorization.

*Unlike opt-out advertising, which allows the recipients of advertisement to discontinue any unwanted advertisements from the sender, opt-in advertising allo

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

s the advertiser to request to have specific advertisement sent. The recipient may allow or deny permission to have further advertisement sent. If allowed, the advertiser immediately includes that e-mail address to its distribution list. Another option is, double opt-in advertising, which is similar to opt-in advertis

.

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

ing except that once the recipient grants permission to send advertisements, a confirmation request is sent to the recipient to verify that they did, indeed, allow the permission. The e-mail address is added to the distribution list only after the recipient has positively responded to the confirmation request.

CAN-SP

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

Companies that provide selfless information through particip

M is not intended to provide cause for the general public to sue spammers, individually or in class action suits. It is designed to allow enforcement by the FTC and other federal agencies for the benefit of the general public. Individuals remain privy to the state laws and regulations of their particular jurisdictions

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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If you are an internet enterpreneur and wants to start making money online, then one of the fastest and most effective thing to do is to create review pages wherein you can do a review of different products (which you are affiliated with I would say) because this will make you a lot of money online.

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