Advice Pool - Business

Many lawyers are cutting costs due to competition. Yes, even la

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

wyers have competition these days even though they seem to have

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

Examples of combination products may in

an unlimited number of people to sue. This is because there ar

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

e so many lawyers each year graduating from Law School and desp

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

ite what you think the Bar Exam is really a piece of cake; lawy

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

Combination pro

ers just complain about it to make you think they are smart.

O

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

f course the big law firms have the most clout, political conne

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

ctions and therefore a small town lawyer maybe way out of his o

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

r her league as a solo professional and can get buried in the p

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

rocess and therefore as a client it might make sense to allow s

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

ome of these small town lawyers who cannot make it in the big l

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

Following aspects would a

eague to go out of business on their own without prolonging thi

dd to the challenges in developing combination products:

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

s by hiring them. Additionally, as a client if your small town

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

lawyer solo-professional cannot do the job you will lose your c

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

ase and therefore wasted all your money fees and still lose.

O

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

ne thing I love is to watch these solo-professional lawyers get

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

Professional from academic institutions, pharmaceutical industries, health care indust

slammed by the bigger city lawyers. Of course I also love to s

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

ee the solo-professional lawyers slam the big lawyers too. As a

.

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

matter of fact my favorite lawyer is one who sues other lawyer

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

Companies that provide selfless information through particip

s or is no longer amongst the living. 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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Advice Pool - Small Town Solo Professional Lawyers and Your Options

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