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As you sit at your coffee table each month, writing check after to check to pay off various bills, do you ever stop to think why a check looks the way it does? What are all those num

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

bers for? Why do I have to write out the amount in words? Why am I writing a check when I can have this amount automatically deducted from my account? That last question you’ll have

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

Examples of combination products may in

o answer yourself. But if you’d like to know a little bit more about checks and how they work, read on.

Here’s a little guided tour of your personal check. Start at the upper left c

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

orner. There you’ll possibly see a cute monogram or logo, something you selected to personalize your checks. Moving clockwise you’ll see your name, address, and optional information

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

ncluding your phone number, driver’s license number, or social security number. Scanning further to your right, above the “Date” line, you’ll see a tiny set of numbers that should lo

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

Combination pro

k something like “9-5678/1234”. This fractional number identifies your banking institution. Next to that, in the upper right hand corner of the check, is a number four digit number.

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

This is your check number, it’s there to help you to keep track of all the checks your write.

Moving on, just below the check number is the dollars box, where you write the numeric

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

mount of the check. To the left of that is the “Pay to the order of” line, where you’ll fill in the name of the lucky person or institution who will receive your hard-earned cash. Be

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

ow that line you’ll find the amount line, where you fill in the amount of your check in words. Directly below that is the name of your bank and possibly its address. To the right of

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

the amount line, you’ll probably notice a little padlock icon. This is a reference to security features built into the check to help your bank prevent or identify fraudulent activiti

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

s. There are more details about these features in small print on the back of the check.

Directly below the amount line and padlock icon, you’ll notice either a small blank area or a

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

Following aspects would a

personal message of your choosing. This is called the “over signature area”. Below that is a line where you sign your name, making your check official and allowing the payee to cash

dd to the challenges in developing combination products:

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

it. To the left of the signature line is a “for” or “memo” line, where you can write a brief explanation of what the funds are to be used for (e.g., May electric bill, September cabl

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

, etc.).

Underneath the “memo’ line, you’ll see a bunch of funny looking numbers. They look that way for a reason. The printing of those numbers is done by a process called magnetic

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

ink character recognition (MICR). These important numbers are printed so they can be recognized by devices called reader/sorters that help expedite check processing. The first nine d

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

igits represent your bank’s routing number. It always starts with 0, 1, 2 or 3. To the right of that, you’ll find two more sets of MICR numbers, set in different orders depending on

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

Professional from academic institutions, pharmaceutical industries, health care indust

the check. One of the digit sets will be your checking account number, the other will be your check number (the same as the number in the top right corner of the check). Flip the che

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

k over, and you’ll see a line for the payee to endorse the check and that verbiage about the safety features built into the check that we talked about earlier. If you hold the back o

.

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

f the check up at an angle, in the right light you might see a watermark—another built in security feature.

That’s pretty much it! Now you know why a check looks the way it does. So

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

Companies that provide selfless information through particip

the next time you’re busy paying bills, you’ll be more enlightened about that little piece of paper that is oh-so-good at draining your bank account. That counts for something, right

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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