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NOTE: THIS IS ARTICLE IS FOR INFORMATIONAL PURPOSES ONLY. IT IS NOT INTENDED TO BE CON

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

STRUED AS LEGAL ADVICE.

There are numerous legal considerations every entrepreneur mu

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

Examples of combination products may in

st face when starting a new business, and raising startup capital is one that can be f

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

raught with danger. Hiring a qualified securities attorney is not a luxury; it’s a nec

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

essity for businesses seeking to raise capital from third parties. Some of the key gen

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

Combination pro

eral considerations are:

• Properly organizing the company as business entity under s

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

tate law;

• Ensuring the company has issued enough authorized shares of stock of the

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

same type that will be offered to investors;

• Make sure that any existing and potent

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

ial legal problems are resolved before issuing stock to investors;

• Have an experien

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

ced securities attorney examine the federal securities laws, as well as the securities

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

laws of any state in which stock may be offered to prospective investors, to make sur

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

Following aspects would a

e the company and its investment offer complies with those laws;

• Have your attorney

dd to the challenges in developing combination products:

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

explain in writing the potential personal liabilities of the company’s officers and d

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

irectors if the company violates any federal or state securities laws in raising capit

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

al. Potential penalties can be very serious, ranging from civil fines to jail time;

•

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

Make sure that your written investment prospectus contains all required state and fed

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

Professional from academic institutions, pharmaceutical industries, health care indust

eral disclosure language in the appropriate places;

• Your attorney should review the

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

business plan and financial statements for possible untrue and/or misleading statemen

.

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

ts; and

• Obtain a written opinion from your attorney whether your particular investm

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

Companies that provide selfless information through particip

ent opportunity is required to be registered with the appropriate regulatory agencies.

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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