Answers - Finance

The basics of a federal tax return are:

1. First find out if you need to file a federal tax return.

2. If yes,

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

then make sure you use the right forms. Start with Form 1040. Details of which forms are to be used when are clea

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

Examples of combination products may in

ly given in the Internal Revenue Service website. A w-2 or 1099MISC are needed to accurately file a Federal tax r

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

turn. All tax payers are scheduled to receive their forms before Feb 15th. Not attaching the correct forms will c

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

ase delays in processing of tax returns.

3. Determine clearly your federal tax filing status. Information on whe

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

Combination pro

her or not you need to file federal tax returns is given at http://www.irs.gov/individuals/article/0,,id=96623,00

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

.html .

4. Calculate your taxable income in accordance with current rules. If in doubt consult a tax expert. All

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

check payments must be made out to the “United States Treasury.”

5. Use online tools like a federal tax estimato

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

to calculate tax payable. Laws chage each year so stay updated with the most current laws. The IRS site has all

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

he information pertaining to tax filing.

6. Log on to the internet and get aquatinted with tax rates for the cur

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

ent year.

7. Use the convenience of e-filing and pay tax online through secured channels using your credit card.

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

Following aspects would a

There is a system known as the Electronic Federal Tax Payment System, EFTPS which allows tax payers to schedule

dd to the challenges in developing combination products:

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

ecurring payments directly from their bank accounts.

8. Be systematic in keeping records and file according to r

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

les. Always attach all documents required and if you are mailing the Federal Tax Return then use the sticker prov

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

ded by the IRS.

Tax returns need not be a burden if you take the time to find out how it is to be done. Many in

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

ividuals file their own returns. Step by step instructions and guidelines are given in the IRs booklets and websi

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

Professional from academic institutions, pharmaceutical industries, health care indust

te.

Be organized and don’t wait until the last moment to file your taxes. Throughout the year maintain records a

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

d be disciplined enough to spare a few hours each month or quarter to keep tax related paper filing and records u

.

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

to date. With the advent of computers tax filing has become easy, you just need to get the appropriate software

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

Companies that provide selfless information through particip

nd all your troubles will be minimized.

Federal taxes can be handled easily if you are organized and disciplined

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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Answers - The Basics Of Federal Income Tax

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