Advice You - Business

Several states have small business government grants. These are not offered by the federal government but a number of state-run developme

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

nt agencies provide free government grants. The states that offer these are Kansas, Nebraska, New Hampshire, New Mexico, and Utah. Other

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

Examples of combination products may in

tates provide financing through loans with incentives to those who want to start a small business rather than free government grants.

In

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

stead of money the government will give free advice and training to those who want to make their business grow. The United States Governm

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

nt's Small Business Administration (SBA) is where the free government grants originate from. Since fifty percent of the labor force comes

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

Combination pro

from the twenty five million small businesses in the United States and that contributes more than half contributes to more than half of

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

he country's gross domestic product (GDP), there isn't much question why the government is interested in the quandary of the small busine

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

ssman.

The free government grants come with free counseling, training, and technical assistance. The Small Business Development Centers

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

SBDCs) have full and part time staff that will get help from the private sector to give the business whatever help that they need. This h

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

elp usually comes in the form of consultants, engineers, and testing laboratories. The grants offered can be found in the Catalog for Fed

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

ral Domestic Assistance (CFDA) website http://www.sfda.gov under the "Small Business" and "Small Business Person" beneficiary category. Y

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

Following aspects would a

ou can browse this free government grants for small business at CFDA free of charge.

The SBA has no funds of its own actually available

dd to the challenges in developing combination products:

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

o supply to small businesses. They depend on the private sector such as banks, credit unions, coops, etc. to provide loans then they guar

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

antee the loans. These loan programs are Loan Guaranty Programs, SBA LowDoc Loans, SBA Express Loans, and Microloan Programs. Targeted Lo

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

n Programs are also offered such as defense-delta loans, CAIP loans, Pollution control loans, and Export Express Loans. These loans are m

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

eant to target or meet specific needs. Since these places are all ready aware of the SBA you only need to mention SBA for the banks etc.

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

Professional from academic institutions, pharmaceutical industries, health care indust

o know immediately what to do.

While free government grants could of course be very useful to any business. The help that a business rec

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

eives need not be money to be useful. The advice that a business receives can be just as invaluable. The professional service could be wo

.

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

th more than money itself. As the old line says "give a man a fish and you feed him for a day, teach a man to fish and you feed him for l

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

Companies that provide selfless information through particip

ife." The success of these businesses can only be beneficial to the government in the long run so the advice given is definitely the best

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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