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If the tax you owe is less than the total of the amount of refundable tax credits that you can

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

claim and the amount of the withholding that you paid, then you can expect a tax refund. Why? T

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

Examples of combination products may in

e most recent tax law provided for a new 10% tax bracket. This means that, depending on your ta

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

x category, the first $6,000 to $12,000 of your earnings will be taxed at 10 percent instead of

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

15 percent. To a lot of Americans, this seems like good news. But is it really?

Many financial

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

Combination pro

experts are quick to interpret the tax refund as a loan that the government borrowed from you

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

a loan that it is now paying back to you, interest-free. For this reason, some people see tax

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

refunds as an inadequate premium. It is nothing more than excess money you paid, which the gove

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

nment used, and is now giving back to you with no interest.

For a greater majority, however, t

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

ax refunds are mere ‘savings’ – money that the government kept for you that you are now going t

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

get back for use in other things. Many Americans are pleasantly surprised to receive tax refun

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

Following aspects would a

ds each year. Most people use the money to pay off debts, beef up savings accounts, and even go

dd to the challenges in developing combination products:

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

on vacations.

To get your tax refund you have three options. You can either let the government

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

directly deposit your tax refund into your bank account, have a check mailed to you, or apply

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

our refund to next year's income tax.

Bank of America, Wells Fargo, and other major banks have

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

a routing number exclusively for direct deposits, which can make your life easier. However, if

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

Professional from academic institutions, pharmaceutical industries, health care indust

your account is with a credit union or other type of financial institutions, your tax refund ma

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

y be rerouted to another institution. Be sure to verify the routing number with your credit uni

.

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

n, because it is not always correct on the check. Also, remember that the IRS will not advise

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

Companies that provide selfless information through particip

you or your bank that your tax refund has been deposited, so it’s your job to do follow-up work

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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