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You did your Taxes and much to your surprise you owe IRS. Not a lot, but more then you have in your savings account.

You delayed mailing your taxes because you did

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

not have the money to pay IRS; this was your second mistake. (Your first mistake was not allowing your Employer to take more taxes out of your pay check each month)

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

Examples of combination products may in

eople get into trouble because they mistakenly believe that they need to pay the balance due when they file their tax return. Yes, it is best to pay when you file yo

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

r return; however, if your cash flow won't allow a full payment there are other options.

If you send in your tax return at 11:49 PM on April 15, and you owe taxes, a

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

d you do not include the amount owed with the filed taxes -- it will take about 5 weeks before IRS contacts you. You will get 4 notices from the IRS every five weeks

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

Combination pro

. It will be right around the first of September, when you will receive a certified letter from IRS. This is when they give you a 30 notice of Intent to Levy! (Thi

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

time table is not set in stone; it can and sometimes changes depending on IRS)

One way that you could have avoided the dreaded "certified mail" from IRS was to send

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

a partial payment with your tax return on April 15. Then send another partial payment when the second notice arrives and another partial payment when the third notic

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

arrived and then paid the balance when the 4th notice arrived.

If it is too late for the above method, then by all means contact a trusted Tax Professional ASAP. Y

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

ou will need help BEFORE you receive the Notice of Intent to Levy. (This is when IRS garnishes your wages and they usually take out more then 50%)

You could contac

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

IRS yourself, but it is not advisable. It is a federal offense to lie to a Federal Agent. You may not plan to lie to them -- but why take the chance? If you tell

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

Following aspects would a

RS the truth without explaining the conditions, you could end of having to pay more then you can afford each month.

For example, you are suppose to receive child sup

dd to the challenges in developing combination products:

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

ort for your child each month. The child support is considered income, but if you forgot to tell them that your Ex did not pay the support payments 7 out of 12 mon

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

ths last year -- you could be in trouble.

Another example; Your Ex said he/she would pay the support each month, you have enrolled your child into a private school -

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

not realizing that IRS does not consider private school as a necessary monthly expenditure you mistakenly thought your monthly tax payments would be lower because of

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

your high expenditures.

Another common example of why you may need a Tax Professional is; You spend $125 a month for top of the line cable choices that will give yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r children the best possible viewing of Education and Disney movies -- in the past, IRS has not considered cable as a necessary monthly expense. So IRS, more then l

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

ikely, will decide that you have at least, $125., plus a good portion of the private school cost and any additional monthly cash flow to pay your Tax bill!

And, on t

.

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

p of all of this, the penalties and interest is compounding daily. A Tax Professional can not change your monthly expenditures, but he/she can help you to remember t

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

Companies that provide selfless information through particip

include the dry cleaning cost, the cost of the dog's food and the dental bill that you forgot about!

Did I say it might be a good idea to contact a Tax Professional

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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