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Accounting is the art of analyzing and interpreting data. It may not be apparent to some but every business and every individual uses accounting in some form. An individ

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

ual may knowingly or unknowingly use accounting when he evaluates his financial information and relays the results to others. Accounting is an indispensable tool in any b

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

Examples of combination products may in

usiness, may it be small or multi-national.

The term "accounting" covers many different types of accounting on the basis of the group or groups served. The following are

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

the types of accounting.

1. Private or Industrial Accounting: This type of accounting refers to accounting activity that is limited only to a single firm. A private acc

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

untant provides his skills and services to a single employer and receives salary on an employer-employee basis. The term private is applied to the accountant and the acco

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

Combination pro

unting service he renders. The term is used when an employer-employee type of relationship exists even though the employer is some case is a public corporation.

2. Publi

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

c Accounting: Public accounting refers to the accounting service offered by a public accountant to the general public. When a practitioner-client relationship exists, 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

accountant is referred to as a public accountant. Public accounting is considered to be more professional than private accounting. Both certified and non certified publ

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

c accountants can provide public accounting services. Certified accountants can be single practitioners or by partnership ranging in size from two to hundreds of members.

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

The scope of these accounting firms can include local, national and international clientele.

3. Governmental Accounting: Governmental accounting refers to accounting fo

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

r a branch or unit of government at any level, may it be federal, state, or local. Governmental accounting is very similar to conventional accounting methods. Both the g

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

Following aspects would a

overnmental and conventional accounting methods use the double-entry system of accounting and journals and ledgers. The object of government accounting units is to give s

dd to the challenges in developing combination products:

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

rvice rather than make profits. Since profit motive cannot be used as a measure of efficiency in government units, other control measures must be developed. To enhance c

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

ontrol, special funds accounting is used. Governmental units can use the services of both private and public accountant just as any business entity.

4. Fiduciary Account

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

ing: Fiduciary accounting lies in the notion of trust. This type of accounting is done by a trustee, administrator, executor, or anyone in a position of trust. His work

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

is to keep the records and prepares the reports. This may be authorized by or under the jurisdiction of a court of law. The fiduciary accountant should seek out and cont

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

Professional from academic institutions, pharmaceutical industries, health care indust

ol all property subject to the estate or trust. The concept of proprietorship that is common in the usual types of accounting is non-existent or greatly modified in fiduc

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

iary accounting.

5. National Income Accounting: National income accounting uses the economic or social concept in establishing accounting rather than the usual business e

.

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

ntity concept. The national income accounting is responsible in providing the public an estimate of the nation's annual purchasing power. The GNP or the gross national p

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

Companies that provide selfless information through particip

roduct is a related term, which refers to the total market value of all the goods and services produced by a country within a given period of time, usually a calendar year

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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