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As one citizen to another perhaps you will join me in my frustrations over the ov

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

erregulation and bureaucracy of our government. Our government is our government

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

Examples of combination products may in

it is not their government or anyone else's. It belongs to the people and our gov

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

rnment does not belong to the nation-state of Mexico or Venezuela or the EU. The

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

United States government is not the French government, is not the British governm

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

Combination pro

nt, is not the Saudi Arabian government and it is certainly not the Chinese gover

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

nment.

We own our government and it is time to slash regulation and bust the bur

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

aucracy. All these laws and rules which are supposed to protect the American peop

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

le are limiting our freedom and our pursuit of happiness. It should be evident f

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

om anyone who is generally an observant person to see what is going on and yet we

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

have politician after politician standing at the podiums and promising as they a

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

Following aspects would a

re going to make things better by making more laws.

Can't they realize that it i

dd to the challenges in developing combination products:

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

all their burdensome laws and rules which are choking our nation's productivity

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

and costing jobs and hurting American Families? They claim the laws are to protec

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

us? Or are they really created to imprison us? Tell you what, it is obvious to m

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 no one seems to care anymore and no one is serious about what is going on here.

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

Professional from academic institutions, pharmaceutical industries, health care indust

So, when you are ready to Slash Regulation and Bust Bureaucracy, then and only th

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

en you can give me a call.

Other wise, things will just go on the way they are u

.

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

til all the froggies in the pot are boiled alive and then whose fault will that b

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

Companies that provide selfless information through particip

e? Not the Mexicans, Chinese or French, no, that will be our fault, see the point

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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