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When it comes time to start a business, many people just get on with the process without really thin

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

king about issues like taxes, liability and business entities. This can lead to unintended consequen

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

Examples of combination products may in

ces.

If you start a business and are the sole owner, you are automatically considered a sole propri

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

etor. You have no protection from liability for the debts of the business and you file your taxes on

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

Schedule C of your 1040. Most people understand this, but what happens if there are two owners and

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

Combination pro

no business entity is selected?

To the surprise of many, a business with two or more owners that do

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

es not actively form a business entity is considered a general partnership. A general partnership is

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

generally not an entity that should be used unless you absolutely must. Why? Well, the entity provid

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

es no liability protection to the owners. If you partner takes a client to lunch, has a few drinks a

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

nd then crashes into another car on the way back to the office, he, you and the business are all lia

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

ble for any lawsuit judgment.

Another area where a general partnership can be problematic is the ad

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

Following aspects would a

ministration. Since most businesses default into a general partnership, the owners have nothing in w

dd to the challenges in developing combination products:

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

riting regarding their wishes. What happens, for instance, if one is disabled or dies? Unless someth

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

ing is in writing, the issue will default to the courts where a judge will make a determination. Obv

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

ously, such a process is both expensive and time intensive.

All and all, general partnerships shoul

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

d be avoided wherever possible when running a business. Alternatives that provide superior liability

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

Professional from academic institutions, pharmaceutical industries, health care indust

protection include LLCs, corporations, limited partnerships as well as other entities. The “best” c

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

hoice for your business depends on the specifics of your situation.

If you find that the general pa

.

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

rtnership is really the only way for you to go, then it is vital you enter into a written partnershi

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

Companies that provide selfless information through particip

p agreement with your partners. Don’t leave it to a court to interpret! Trust me. You will regret it

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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We've all heard it. Employees Hate Change. Do you believe it? I don't. I think employees are getting a bum rap. I think they are being used as an excuse for poor change, poor results, poor communication, poor planning.

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