Advice You - Internet and Businesses Online

The internet is a wonderful thing, except for a few small details. When you register your first domain name, you get your introduction to one of them. There's a lot of information they want. Your name, your email address, your physical addres

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

s, your phone number. For each of 4 separate categories, and the Registrant, Admin and Technical categories are publicly available (for almost all TLDs - Top Level Domains, with the possible exception of .ws - Western Samoa).

Email addresses,

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

Examples of combination products may in

which must be valid, phone numbers and physical addresses which also must be valid. I personally think it's both absurd and dangerous to make this information so easily available. Once again the right to privacy of law-abiding individuals is

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

being abridged supposedly to help catch lawbreakers. Since this information would be provided under a court order, making it publicly available just invites abuse.

Spammers, scammers, stalkers and the idle whacko can easily get this informat

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

ion. And it's a nice start on identity theft, too. However, for most people, the most likely result is an increase in the amount of spam you get. But, much worse can and has happened.

So what solutions are there? Basically there two ways to

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

Combination pro

protect your privacy if you are a private individual without access to a legal entity such as a company to own the domain name (note that if it is a company, you must provide accurate information. This only moves the problem to a slightly le

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

ss personal level).

First you could lie. No, that's not one of the ways. Unwise and illegal too, and you are a law-abiding type, right? So, first, a proxy registration is one alternative.

Essentially you make a binding legal agreement with

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

a company which will register the domain name as if they owned it and then provide their own information to meet the requirements. For each domain, they will set-up a special email which they will monitor and forward to you, usually after spam

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

filtering, if you want them to.

They, of course, retain your data and will also monitor physical mail. You will be notified of first class mail which appears to or could be legal documents or if registered or couriered mail arrives. They wil

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

l, for a fee, ship such to you, if you agree and pay. Generally such items would be sent by courier. Phone callers will be directed to use the email or physical address shown in the WhoIs record

Of course, under subpoena or other specified co

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

nditions they will provide your details. You will have full rights as owner - as long as you behave and don't violate the agreement.

The other alternative, usually called "private registration", is a little different. Here your name would st

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

Following aspects would a

ill appear as registrant. You would provide the names of the admin and technical contacts. But the address, email and phone number would be provided and monitored by the organization handling the private registration in essentially the same ma

dd to the challenges in developing combination products:

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

nner as a proxy registration. Thus with this alternative you remain in full legal control of your domain name since it is registered in your name rather than the name of a proxy.

On the face of it this second alternative sounds better, but yo

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

ur name is hanging out there on view and you may have valid reasons for not wanting that (perhaps the company you work for takes a dim view of moonlighting, or you have had a stalking problem or are doing something perfectly legitimate but don'

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

t want your name linked to it).In that case, a proxy registration is the only real alternative.

In case you're thinking you can hide out and do whatever sort of bad stuff behind a proxy or private registration, don't even dream about it. Thes

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

e outfits take it very personally if you misbehave and the legal agreements spell it out.

If you decide to pursue a proxy or private registration, make very sure that you are working with a legitimate company with a track record. A domain nam

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

Professional from academic institutions, pharmaceutical industries, health care indust

e can be a very valuable possession. Both your registrar and, if it's a separate organization, the entity that does the proxy or private registration must be quality, legitimate outfits. Registrars offering extremely low prices which are way o

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

ut of line with the going rates - unless it's a special - just might be after your credit card and identity. Also, this time, actually read the agreement and TOS so you do know what you're doing and what could happen under what circumstances.

.

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

Wondering why I'm writing about this? Well, it's because I'm getting more and more spam and I started doing some research on possible solutions. And I figured, I wan't the only one looking to do something about the problem. And then, I disco

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

Companies that provide selfless information through particip

vered that some registrars will provide free proxy or private registration with your domain name purchase. So think about it and do some checking before you buy a domain name. Your privacy is a precious possession.

Copyright 2005 Richard Keir

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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