Advice You - Business

The ATF often comes under fire from civil rights groups because many citizens feel that the right to ba

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

re arms should not be limited in any way. All too often we see pictures on the television set of the AT

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

Examples of combination products may in

raiding some household or business and going in to get the bad guys. This concerns many citizens beca

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

use they believe that most often this is a violation of our civil rights and that there are too many la

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

s controlling firearms. They believe that in the Constitution the right to bare arms was not meant to

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

Combination pro

be limited.

Still some folks get a little nuts and might start buying up army tanks and 144mm Howitzer

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

rounds. Some of these people believe that as the weapons of the bad guys get better that they need bett

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

er weapons to protect themselves. If the bad guys have machine guns, then the good guys the machine gu

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

s to and if the U.S. citizen believes they are the good guys, then they have a problem with the ATF.

I

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

t would be best for the ATF to work harder on public relations rather than just having a web site up wi

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

h information. In fact the ATF needs to do more in its public relations efforts as to not alienate US

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

Following aspects would a

citizens. This means the ATF needs to be on good terms with all the media outlets and have constant co

dd to the challenges in developing combination products:

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

munication lines free and clear.

When the ATF raids a location, generally they do not talk about it mu

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

ch and everybody tends to wonder exactly what the real story is. Of course this branch of law enforcem

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

nt cannot give away all the information because if they do they will tip off other bad guys as to their

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

tactics, strategies and the fact that they are hot on their trail. The US citizen on the other hand mi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ht be paranoid that the strong hand of government is working very hard to disarm them.

This causes the

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

conspiracy theorists to come out in mass and silently protest amongst them. When this happens we have

.

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

a divide between the government and the people. If the ATF wants to cross that divide of democracy the

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

Companies that provide selfless information through particip

n they must do so through public relations programs that makes sense. Please consider all this in 2006

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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