Answers - Legal

Well I have retired at 40-years old and it is not because I am lazy, stupid or want to kick b

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

ack. It is because I just got tired of beating my head against the wall filling our forms, de

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

Examples of combination products may in

ling with all the over regulation in industry and then having to watch lawyers over charge an

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

d take all the cream off the top. Personally I think Caesar was right and Vice President Dick

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

Cheney who popped one full of Bird Shot is now my personal Hero.

While in the Franchising Se

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

Combination pro

tor as a Founder, I cannot tell you the amount of over regulation we had to deal with. But th

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

at is only one industry. How about doctors and malpractice and those suits affect our health

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

nsurance rates, sure some doctors are really incompetent just like some lawyers are incompete

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

nt and I have even met franchisors that are incompetent as entrepreneurs.

But in all if thei

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

were fewer lawsuits and everyone could do handshake deals like our grandparents then in fact

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

business, educational systems, police protection could move smoother with less red tape and b

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

Following aspects would a

etter results. Government’s number one job is to protect her citizenry, yet we constantly in

dd to the challenges in developing combination products:

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

erject attorneys and lobbyists into the loop for special interest group’s rights, without act

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

ually serving the people our leaders are sworn to protect.

Why should a mobile car wash busi

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

ess franchise need a 210-page pre-sale legal disclosure document? It doesn’t, but over the y

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

ars the average franchise documents have increased and ours is actually on the low side. The

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

Professional from academic institutions, pharmaceutical industries, health care indust

bigger they get the less they help the customer (franchisee), and give more power to the Cor

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

oration. That is truly a travesty. What an insane amount of paperwork for the privilege of c

.

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

reating opportunity, jobs, tax base and providing consumers with their desires. What a way to

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

Companies that provide selfless information through particip

repay the greatest asset in our nation. It is the ultimate disrespect for those who give 110%

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 and Over Lawyering Killing American Commerce

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