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The date for submission of tax returns for 2007 is April 17th. In case you miss the deadline for some reason you must still file a

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

return as soon as possible. In case you owe taxes the IRS will impose fines, interest on money owed, and penalties. However, if a

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

Examples of combination products may in

refund is due then interest and penalties will not be imposed. The IRS rules state that to get a refund you must file the return

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

within three years of the due date.

For late filing of tax returns you may need:

• Form 4868 – application for automatic extensi

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

n of time to file US Individual Income Tax return.

• Form 4848 (SP), application for a Spanish version.

• Form 1127 application

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

Combination pro

for extension of time for payment of tax.

• Form 2350 application for extension of time to File US Income tax.

When filing a lat

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 tax return you must:

• Request for an extension of time to file the return. The four month extension is only for filing, all ta

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

es that are due must be paid in full. Request for an extension can be made by calling: 1-888-796-1074. Or, e-file form 4868. Or

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

mail a form to the IRS using certified post.

• If you are unable to pay the taxes due in full, request the IRS for account resolu

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

tion packages. Request permission to pay the taxes due in installments. Never avoid filing a tax return.

• Be honest and file acc

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

rate returns and find out from the IRS what procedures are to be followed for late filing of tax returns.

• If the procedures for

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

Following aspects would a

late filing seem too complicated consider taking the help of a tax professional who has several years of experience dealing with

dd to the challenges in developing combination products:

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

late filing of tax returns and knows the laws inside out. Tax professionals will be able to deal with incomplete documentation and

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

deal with IRS negotiations regarding your taxes, penalties, or interest.

• Find out all about IRS tax penalties and interests ch

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

rged. Considerable information is at the IRS web site.

• Before you file late tax returns find out what the “statutes of limitati

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

ons” are and plan your tax strategy taking these into consideration.

• Check your returns thoroughly and ensure that all document

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

Professional from academic institutions, pharmaceutical industries, health care indust

s are in place.

• Sit down and plan on how you will get out of tax debt. And in case there is an IRS investigation, levy, or lien

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

how you are going to present your case.

• Take the help of tax professionals and plan on how you will get out of trouble and stre

.

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

amline your tax payments so that you get back on schedule.

Review your overall tax situation and find ways to reduce your taxes,

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

Companies that provide selfless information through particip

make tax payments in time, and organize your financial documents in a way that you are able to file tax returns on time every time

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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