Answers - Legal

We have many laws to protect us from Corporate Securities Fraud and Small

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

Business Scam Artists. We have laws to protect us from Gangs, Child Mole

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

Examples of combination products may in

ters and Drug Dealers. We are protected from International Terrorists and

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

foreign invading armies. But who is protecting us from the protectors? A

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

d to that point who is protecting us from abuse of power in government re

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

Combination pro

ulatory bodies? Who is watching OUR government, which is so busy watching

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

us, supposedly to protect us that we have stopped watching it.

Over the

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

years I have learned not to trust government regulators or the lobbyists,

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

competitors or complainers who file bogus accusations. I often do not tru

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

st government investigators, as they start out with a premise and then wo

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

k to prove themselves right, in case they can't, well they just keep sear

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

Following aspects would a

hing until they find something else, anything so they can justify their t

dd to the challenges in developing combination products:

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

ime spent and taxpayer’s dollars used in the investigation. When they can

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

ot find something wrong they make something up and then hide their tracks

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

It is unfortunate that we allow our government to do this and even more

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

unfortunate that they charge their targets or innocent victims for their

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

Professional from academic institutions, pharmaceutical industries, health care indust

costs in all this harassment. It is sickening the way government regulato

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

s treat businesses in this country. And I wonder, then as I question auth

.

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

ority; Who is watching the Federal Regulators of our nation? I fear the a

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

Companies that provide selfless information through particip

swer is indeed No Body. Gee, what did they say about absolute power again

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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