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If you have a Blog and lots of participants then perhaps you have considered rules to help guide the dia

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

logues? Generally Blogs are places where concepts and ideas are discussed so you might even discuss the

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

Examples of combination products may in

otential rules with those who will be participating on your Blog? For instance; What are your thoughts o

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

the New Blog Rule Policy?

You might get some interesting answers back too such as; “The Policy is Okay

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

as far as Policies Go? But are you sure you need a policy for this Blog?” If this is the case perhaps yo

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

Combination pro

need to ask yourself the question, are the rules really needed? How often is the Blog abused and how of

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

ten do people attack others personal character.

You should never ask for input on what to add to rules

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

nd regulations, rather you should ask what could be removed. Why you ask? Well because fewer rules are a

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

tually better. Yes, the rules should be reduced to three main rules, like Isaac Asmiov's rules for Robot

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

. Keep it simple and easy to remember;

1.) Be Nice, ie "golden rule" and no swear words

2.) Work hard

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

o stay on topic without self-promoting.

3.) Only original comments here, do not post private emails, ot

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

Following aspects would a

her people's work.

The more simplistic the better is my point and to that point one rule could be to us

dd to the challenges in developing combination products:

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

"Common Sense" as that would be the same as the 1-3 here. Of course common sense is pretty much a dying

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

concept for over regulation, political correctness and over-lawyering.

So, in the end why bother to mak

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

rules at all? There are enough forums and blogs out their with similar guidelines and they are pretty s

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

andard, so? Why not just say; "This is a Blog" and we would expect you follow Common Sense and Standard

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

Professional from academic institutions, pharmaceutical industries, health care indust

Blog Etiquette?

I certainly hope this article is of interest to you and helps you with your rule making

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

session. Fewer rules mean better flow of thought and therefore it makes sense to see if you cannot reduc

.

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

the number of potential rules for the Blog before you start. And if you can get away with it, then simp

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

Companies that provide selfless information through particip

y wait to make a set of rules until there is a real issue. Perhaps this will help propel thought in 2007

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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