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If you’ve made the decision to apply for a secured loan, you’re likely to have done a bit of homework in regards of current interest r

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

ates, traditional fees for preparing the necessary documents, and of course, the fee your lender will charge you for your secured loan

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

Examples of combination products may in

If you have yet to accomplish the above tasks, you should at least begin the process before you begin to contact potential secured l

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

nders. So here’s a bit of basic info for you (and if you’re already familiar with it, let’s just consider it a refresher course, shall

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

we?).

The most common type of secured loan is a mortgage; one of the largest bills that you will ever have in your life. There are

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

Combination pro

wide variety of fees in all shapes, sizes and colors for you to decipher through, so be sure to pack your x-ray goggles!

First thing

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

first, we have the APR – it’s the amount that you will be paying each year for your loan. Also known as the Annual Percentage Rate, i

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

t will include the interest rate, fees, and certain other charges calculated on a yearly basis to come up with one complete percentage

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

It’s usually a bit higher than the interest rate that you’re quoted, as it includes the other fees.

Be sure that you know the terms

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

for “fees” as many of them can be hidden or covered up as something else. “Points” are one of the more popular fees, and can range in

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

purpose to get you a lower interest rate to an honest loan officer telling you that’s how he’ll fill his paypacket. When in doubt, as

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

Following aspects would a

k questions! If you’re not happy with the answers you received, ask someone else. Ask all the way up to the president of the company,

dd to the challenges in developing combination products:

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

as this is your money we’re talking about here. And don’t sign anything that you’re not 100% sure about.

And last but not least, be s

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

re to shop around- don’t put all of your eggs into one proverbial basket, so to speak. There are, unfortunately quite a few bad loan o

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

riginators (often referred to in the industry as “predators”) in the secured loan industry that are completing the old “Bait and Switc

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

” routine on you- promising the moon and stars to you, their special client, but all the while they have no such program waiting for y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u (and you are now in a difficult position: either choose the horrid loan program that you got switched into, or no loan at all). By

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

shopping around, and informing the competing lenders that they are not alone, you are setting yourself up for an ideal, winning secure

.

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

loan situation.

When the application process commences, it’s very important to remember that you can change your mind at any time wi

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

Companies that provide selfless information through particip

hout penalty or fine. Sometimes our gut instinct tells us something that we just can’t avoid, and it’s often best to listen to our gu

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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