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Reporting your income for tax purposes is a required activity in this world. It can't be avoided, but it can be made a lot easier. There are some simple things you can do, that will make the end of the year burden a lot lighter, it will also give you more time for writing and make you financiall

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

y more successful.

The first item on your agenda should be to keep good records. The simplest record keeping method for a self-employed writer is to use a checking account. Keep the checkbook, up-to-date and balanced. Deposit all your income to the checking account and pay all your business exp

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

Examples of combination products may in

nses from the checkbook. You will not remember that cash expense later if you don’t write it down. Cash receipts get lost or mislaid, income is forgotten or overlooked, and by the end of the year it is impossible to reconstruct what has happened without a systematic written record. The checkbook

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

is the easiest method to use for a single person business. Accountants call it the poor man's bookkeeping system, not very high tech, but it works.

Mileage is another huge problem area for the self-employed. Currently there are two acceptable methods allowed in calculating mileage expense: the

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

ctual expense method and the standard deduction method. The actual expense method requires adding up all gas, oil changes, car washes, repairs, tires and other vehicle expenses and doing a depreciation calculation to compute the total cost of running a vehicle. Then you must multiply by the perc

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

Combination pro

entage of actual use as a business vehicle. For this you need to know actual business miles driven as well as the total mileage put on the vehicle for the year. If you use more than one vehicle you need to do a separate calculation for each vehicle.

The other approved method is a standard deduc

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

ion method. The rate allowed for 2007 is 48 ? ? for every business mile driven. All you need for the standard deduction method is to prove the number of business miles driven, and beginning and end of the year odometer readings. For most people, the standard deduction method works the best. Once

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

you select a method however, there are strict limitations on changing. As an accountant I have run the numbers both ways and generally the standard mileage method is a reasonable approximation of vehicle cost per mile.

In any event, whatever method is selected, use your calendar, keep track of

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

here you go, and why you went there and write down the round trip mileage. You do not need to actually clock the odometer and write down the odometer reading when you started the trip and the odometer reading when you return. You merely need to know, how many miles you went, the business purpose

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

of the trip, and when you went there.

One nice benefit of writing is that travel can be a deducted as an expense if the travel is related to the research involved in your writing. The IRS standard for deducting travel is that the primary purpose of the travel should be related to the business

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

f writing. Travel, which is for a mixed purpose, both pleasure and research has to be carefully documented to establish how much time was spent in research activities and how much of the travel was for pleasure. Fact situations can be murky, but an established writer will generally be allowed co

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

Following aspects would a

siderable latitude in what they can deduct. Hotel, admissions, mileage and other costs of maintaining yourself away from home are all tax deductible business expenses.

There are some specific rules for international travel, and they are a little tougher when travel is for both business and plea

dd to the challenges in developing combination products:

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

ure.

Meals are deductible in two circumstances: for overnight travel, when you are away from home long enough to require a rest period; or when substantial business is conducted during before or after the meal. An interview or presenting a proposal to a client are typical examples of deductible

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

business meals. Keep track of who the meal was with and the purpose of the meeting, as well as the cost, including tip. Remember though if you are across town and stop at a fast food place for lunch that is not a business expense.

Writers benefit from the tax laws when doing research. They are

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

allowed to write off research expenses even though they are not yet receiving any income from the project. The qualifier on this is as the Internal Revenue Code puts it "they reasonably expect they will receive income as a result of their research activities." Normally, a writer’s cash income la

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

s their production by a large time gap. The ability to deduct expenses when they occur is very important. Without this rule a writer could have a negative cash flow and still owe taxes.

Think about computerizing you records. Keeping track of your income, keeping running a receivable list of wha

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

Professional from academic institutions, pharmaceutical industries, health care indust

you are owed as well as all the expense stuff and doing it all totally on paper is a headache. If you merely write an article or two, a list is fine. If you have a score of articles and you're selling reprint rights, movie or television rights and have complex business arrangements, consider a

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

computerized program. QuickBooks quicken or other bookkeeping computer programs work. Don't rely on memory. It's too challenging, you'll never remember it all without writing it down.

And lastly, operate like a business. You are in one, whether you realize it or not, if writing is a full-time j

.

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

b or a limited part-time hobby, treat it like it's a job. Approach it with discipline in the area of record-keeping, expenses and chasing after people who owe you money. Set some written goals and continually ask yourself if you were working for somebody else, other than yourself, “would you be

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

Companies that provide selfless information through particip

oing this?”

Most self-employed business people spend about 15% of their time on administrative tasks. Trying to spend 0% of your time on administrative duties will get you into big trouble. If the business and tax side of what you do is organized, then the writing is a lot more fun and creative

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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This article, written by Marketing Master, Catherine Franz, discusses the pros and cons of two ways to launch a brand, how to pace, and the issues of overcoming the hurdles of credibility and conventional.

Where do you send your letters to editors? The reality of letters to editors is that the smaller the publication, the more likely your letter will be published.

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