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There have been an estimated 9.9 million victims on America and over 40% of all consumer compla

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

ints in the U.S. involve identity theft. About half of the victims do not know how the thief o

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

Examples of combination products may in

btained their personal information. The Boston Globe and Newsweek have both covered Identity t

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

eft this month telling us how important it is for us to educate ourselves on preventing and pro

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

tecting ourselves from this type of robbery. Identity theft can happen anytime, anywhere and t

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

Combination pro

anyone, individuals or businesses. Everyone must be educated and aware so it can be avoided.

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

Michael Blanchard, US Postal Inspector says postal money orders and business or certified che

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

cks are one way you can be at risk. Most identity theft involves the U.S. Mail which is why th

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

U.S. Postal Inspection Service is a lead agency in investigating Identity Theft. Identity The

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

ft is a criminal offense.

What can I do if I am already a victim of ID theft?

• Contact the f

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

aud departments of the three major credit bureaus, to place a fraud alert on your credit file.

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

Following aspects would a

• Close all accounts that have been affected and request copies of fraud-dispute forms and com

dd to the challenges in developing combination products:

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

plete and return immediately. Keep copies!

• File a police report in each jurisdiction the the

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

t occurred

• Send copies of the report to your creditors or anyone that requires proof of the

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

crime

• File a complaint with the FTC (800-IDTHEFT or www.consumer.gov/idtheft) and Post Offic

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

• Contact the Identity Theft Resource center at 858-693-7935 or www.idtheftcenter.org

• Requ

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

Professional from academic institutions, pharmaceutical industries, health care indust

est a new driver’s license from the state of motor vehicles and have a fraud report attached to

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

your driving record.

• Notify check-verification firms about any fraudulent checks:

Internat

.

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

onal check service 800-526-5380
Telecheck 800-927-0755
Certegy Check Services 800-437

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

Companies that provide selfless information through particip

-5120

• Call 1-888-CALL-FCC and file a complaint.

• Change your passwords and PIN immediately

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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