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The IRS has been the subject of an email scam campaign. They are informing the public to be

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

on the lookout for email indicating they are coming from the Agency. Since the IRS does no

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

Examples of combination products may in

t send unsolicited emails asking for your personal information, you must assume these emails

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

are written to trick you into giving out financial and personal information you should not b

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

e disclosing to the public.

The IRS has noticed an increase in the number of scams. Since

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

Combination pro

November 99 scams have been identified. During the tax filing season, forty were identified

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

In June an additional twenty surfaced. Many are originating outside of the United States.

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

Some of the countries are Argentina, Aruba, Australia, Austria, Canada, Chile, China, Engl

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

and, Japan, Italy, Korea, Malaysia, Mexico, Poland, Singapore and Slovakia. Some have come

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

rom the United States.

The IRS will not send you an email requesting personal information o

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

f any kind. They won’t try to trick you into disclosing bank account numbers, pin numbers,

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

Following aspects would a

or credit card information. Since this information can be used for identity theft, you must

dd to the challenges in developing combination products:

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

be aware of everything you do on and offline.

If you give out your personal information, it

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

can then be used to steal your identity and perhaps your financial assets. The IRS has est

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

ablished an email box for you to send suspicious email you receive which appears to have com

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

from the IRS. The email address is : phising@irs.gov. The IRS will investigate your emai

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

Professional from academic institutions, pharmaceutical industries, health care indust

l to determine if it fits into the scam category.

If you experience Identity Theft, the Fed

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

eral Trade Commission has a consumer web site at .

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

ov/idtheft/index.html">http://www.consumer.gov/idtheft/index.html As in all aspects of

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

Companies that provide selfless information through particip

life, do your due diligence before providing personal information to anyone you do not know

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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