Answers - Legal

How do we citizens in the United States of America know that we ar

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

e over regulated? Well it is pretty obvious when the rest of the w

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

Examples of combination products may in

orld starts laughing at us. But it is even more obvious if you con

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

ider all the overregulation in the US on business, in every single

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

industry except one. Lawyers.

Then we see the legislative branch

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

Combination pro

is full of lawmakers who are usually lawyers too and the judicial

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

branch? You guessed it... lawyers. Currently only the executive br

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

nch, the President, is not lawyers thank god. The Vice President s

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

hoots them? Sounds good to me, I hope he keeps taking lawyers hunt

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

ng with him.

It is known or you should have known that these scou

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

ndrels of law have hijacked the law and hold all the business folk

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

Following aspects would a

s out for extortion in high fees. It is almost as if you have to c

dd to the challenges in developing combination products:

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

ll them every time you need to take a dump to make sure it is okay

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

and you are not breaking any rules.

It actually has really gotte

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

that bad, yet all the corporate corruption in Washington DC is fr

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

om lobbyist lawyers and law firms. So why may I ask are we not re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ulating the lawyers instead of harassing all the small businesses

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

who actually have to work for a living without stealing? The reaso

.

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

I ask is that I am hereby calling for a complete overhaul of the

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

Companies that provide selfless information through particip

legal profession and a new set of stringent regulations on lawyers

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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Answers - Over Regulation in Every Industry Except Law?

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