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Main Subject - Can SPAM? Can't Spam? Exactly What Does And Doesn't The US CAN - SPAM Act Do?
In 2003 we saw the introduction of the CAN-SPAM act which, regretably is a step in the wrong direction by the US government.
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
This article provides my own personal opinion of why.
Firstly, let's look at what the act does do. It makes it legal to se
Firstly, let's look at what the act does do. It makes it legal to se
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nd spam, but only in a specific way. It is illegal to send spam through virus infected or compromised machines - but then us
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 of these things is illegal anyway. Spam must be sent from a valid e-mail address, and must provide a valid opt-out method
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
.
Essentially what this means is that spammers can send anyone they want a mail and it is up to the recipient to opt-out of
Essentially what this means is that spammers can send anyone they want a mail and it is up to the recipient to opt-out of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
receiving more. Let's apply this reasoning to other laws - I can rob you once, and if you would prefer I discontinued pleas
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
e send me a letter. I can rape you or kill you - please tell me if you would like me to stop and after this one time. Yes I
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
realise I robbed you before - but that was a house burglary, this is a car burglary which you haven't yet opted out of. Thi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s sort of thinking is obviously non-sensical. If spam is to be regulated against - as it is, and if it is an infringement of
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
peoples rights - as it is, and if you want to stop it - as we do, then why would anyone consider such a farsical law would m
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ake any difference.
Spam is bulk unsolicited mail, but the CAN SPAM act has attempted to redefine it as bulk unsolicited mai
Spam is bulk unsolicited mail, but the CAN SPAM act has attempted to redefine it as bulk unsolicited mai
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l from a hidden address without an opt out. This represents a serious lack of understanding of exactly what the problem is.
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
If you can send the first spam legally, who is to say whether the second spam is a follow up, or a new legal first spamming?
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
A domain name costs a few dollars, and comes with unlimited email addresses, even if someone does opt out of a spam email t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
hey will still likely be contacted by the same spammer, from a different address. In fact, this very policy is likely to giv
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
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
e spammers confirmed lists of people who respond to spam!
One thing the CAN SPAM act does do well is allow ISP's the right t
One thing the CAN SPAM act does do well is allow ISP's the right t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
o handle spam as they see fit. This means that resources like the SPAMHAUS PBL can be used to block spam at it's base.
One
One
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
final point that is often overlooked is that while the USA has attempted to legislate spam, most countries have outright bann
.
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
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
ed it. This means that the same email sent to a US address and, for instance, and english address can be both legal and ille
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
gal. Spammers claiming protection under the CAN SPAM act can only do so within the USA, and can still be prosecuted offshore
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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