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You have gotten to the point where you are ready to accept subscribers to your Ezine. But now comes the decision. Do you want your subscription

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

service to be single of double opt-in? Well, to answer that question, we first have to explain the difference between the two methods. Then we c

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

Examples of combination products may in

an list the pros and cons of each.

Single opt-in works as follows. The potential subscriber sees your ad for your Ezine and the sign up link an

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

simply puts his email in the form, clicks send and he is now a subscriber. He doesn't have to do anything else. You'll have his information del

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

ivered to your system and he will be added to your subscriber base. When your first Ezine goes out, he will be getting a copy of it.

Double opt

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

Combination pro

-in works as follows. The potential subscriber also sees your ad for your Ezine, just like in the example about, except there is one difference.

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

After he submits his email address and clicks send, a message will come up telling him that he will be receiving an email that he will have to r

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

eply to in some form, usually by clicking a link in the email. After he does this, THEN he is added to your subscriber base.

Okay, so what's th

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

e difference? Why make somebody go through the extra step? Isn't single opt-in good enough? This is where we get to the pros and cons of each me

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

hod. You can decide on your own which is best for you.

With single opt-in, after the subscriber submits his info, he is in. This makes it easie

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

r for him to become a subscriber. The extra step may be too much of a bother for him and he will never click on your link, thus he will never be

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

Following aspects would a

come a subscriber. Thus somebody who would have been, is not. You have lost a potential subscriber. Another positive of single opt-in is that th

dd to the challenges in developing combination products:

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

re is less programming involved for the system as there are fewer steps involved. That's the positive side of using single opt-in over double op

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

t-in. Naturally, single opt-ins positive side is double opt-ins negative side.

But there is a downside to using single opt-in. With single opt-

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

in, a subscriber could enter any email address and it won't matter. Why? Because he doesn't have to confirm it. So if your Ezine requires that i

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

be emailed to him, he will never get it. While this may seem silly, some people will do this just to be able to download the freebies before ge

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

Professional from academic institutions, pharmaceutical industries, health care indust

tting their first email. This way they get the freebie and don't have to be bothered with your emails. By having double opt-in it forces them to

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

give a valid address or they don't get any of the benefits. While this may decrease the number of subscribers you get, it will increase the num

.

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

er of serious subscribers that you get. And 100 serious subscribers are much better than 10,000 not so serious subscribers.

There are those who

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

Companies that provide selfless information through particip

will argue in favor of each and that's fine. There really is no right or wrong answer here. It all comes down to what you feel it right for YOU

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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Advice You - Double Opt-In Or Single?

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