Main Subject - Business

The Profit and Loss Statement, also called the Income Statement for accounting, has five important parts: 1) Incomes, 2) Other Incomes, 3) Expenses, 4) Other Expen

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

ses and 5) Net Income or loss. It conveys how the business received and spent monies during the period of the statement. The statement can cover any time period

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

Examples of combination products may in

ut it typically covers monthly, quarterly, or yearly periods. Each of the statement parts shows a distinct piece of the net income puzzle, starting with income.

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 Incomes portion of the statement, in accounting, will summarize all of the incomes received from operating the business. If it sells a product, it will be pro

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

uct sales. If it is a service company, it will be service income. Many companies have both types of income. The major difference between the two types of income

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

Combination pro

relates to the cost of goods sold. For product sales, the cost of the product must be subtracted from the income. If you offer services, there isn't a cost to t

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

e product. Importantly, this income is from doing the entity's main business.

On the other hand, Other Income in accounting - will summarize all income that does

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

n't come from the entity's main business. For instance, if it had extra cash and invested the money, the interest received would be an Other Income because invest

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

ng money is not the main business. In each company, what constitutes monies received from the main business and those received as other income varies with the lin

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

e of business. The important attribute is not just the company making money, but how it is being made. Preferably, it is from doing the main business.

Next, ent

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

ties spend money as a cost of doing business. They must pay utilities, buy machines, hire people and do many other activities. Just like income, all costs relate

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

Following aspects would a

d to the main line of business are expenses. They will be summarized in the Expenses section of the Profit and Loss, in your accounting. Hopefully, these expense

dd to the challenges in developing combination products:

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

won't exceed the income they produce.

Also, there could be some expenses related to making other income. For instance, if the company bought shares of stock wit

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

h the extra money, there could be expenses related to buying and selling commissions. The Other Expenses are then summarized in the other expense section of the s

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

atement.

Finally, we come to the last section of the statement, often referred to as the 'bottom line.' If we take both income pieces, Income and Other Income and

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

subtract both expense pieces, Expenses and Other Expenses, we have the Net Income. This is an essential number to both the owners and operators of the business.

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

Professional from academic institutions, pharmaceutical industries, health care indust

It is the reward the entity received for being in business. If there is more income than expenses, we have a Net Profit. If the expenses exceed the income, we ha

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

ve a Net Loss.

The Profit and Loss Statement then, in accounting, gives us a view of how the business did during the period of the statement. It doesn't say anyt

.

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

ing about what has happened prior to or after the dates on the statement. Too, it doesn't help us predict what will happen or how robust the entity is today. The

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

Companies that provide selfless information through particip

refore, the statement has a very narrow, but important, perspective--One that is used by investors, owners, managers and others analyzing the state of the business

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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