Answers - Legal

Why is it that every single industry is regulated except lawyers? It is really funn

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

y because they are the only ones who are really putting the screws to the American

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

Examples of combination products may in

People. Lawyers are scoundrels and are the scourge of the Earth it has been said. C

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

esar was most likely correct. So why are we not regulating lawyers? If the lawyers

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

are watching over the law, then who is watching the lawyers and why is it against t

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

Combination pro

e law for our own government to ask such questions? Why is it that the FTC cannot r

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

egulate lawyers?

http://www.washingtonpost.com/wp-dyn/content/article/2005/12/06/A

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

R2005120600823.html

Who dares to question the ethical nature of lawyers? I do? Who

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

am I, we I am we and we are the government and I question authority and ask why is

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

it that bankers who we entrust our money to like “In God we Trust” have know your c

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

stomer laws? Yet the Lawyers hide behind the law so they can protect anyone, even c

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

Following aspects would a

riminals for a fee? Something is a miss and it would be nice to know exactly what i

dd to the challenges in developing combination products:

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

s up here? Why are we regulating every single profession and demand disclosure and

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

ransparency so if one single “I” is not dotted or “T” is not crossed a lawyer can s

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

ue the company and screw over the shareholders (consumers), yet when we ask to regu

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

ate lawyers, ah ha, suddenly it is against the law? So, somehow the it appears that

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

Professional from academic institutions, pharmaceutical industries, health care indust

lawyers have indeed hijacked the law, like a kid with the only plastic shovel in t

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

he sandbox and they are saying “Ha Ha, you can’t have it back!” Screw these lawyers

.

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

let’s call Caesar.

If our own government cannot enforce the laws of our land agai

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

Companies that provide selfless information through particip

nst lawyers, then our laws are useless and it is tie for real action. Think on this

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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