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The Blue Sky from American Express is a rewards card designed for those who have very go

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

od credit. With this program, cardholders earn one point for every dollar they spend on

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

Examples of combination products may in

very purchase. There is no limit on the number of miles that can be earned, and they do

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

ot expire as long as the card is active and in good standing. Points can be redeemed for

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

any flight, hotel, rental car, or cruise with no blackout dates or restrictions on trav

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

Combination pro

l. Only one purchase can be made at a time in 7,500 increments, equivalent for a credit

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

f up to $100.

There is a 0% introductory rate for purchases that is valid for six month

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

s, and a 4.99% introductory rate for balance transfers that is valid until the loan is p

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

id in full on transfers that are initiated when an online application is submitted. Afte

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 introductory period, the rate on purchases is a variable rate of 12.99% and 22.99%

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

ariable for cash advances contingent upon credit history. There is no balance transfer f

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

Following aspects would a

ee, but future transfers may incur a fee and will be disclosed at that time. No annual f

dd to the challenges in developing combination products:

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

e is charged for the Blue Sky from American Express Card.

This card is most advantageou

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

to those who plan to utilize the rewards program and pay in full each month after the i

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

ntroductory rate expires. It’s important to keep in mind that not all applicants quality

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

for the introductory rate.

Some of the benefits a cardholder can expect to receive with

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

Professional from academic institutions, pharmaceutical industries, health care indust

this card include the following:

• Online access to account information

• Protection o

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

f purchases

• Financial statement at year’s end (online)

• Return protection

• Extend

.

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

d warranty for purchases

• Insurance for car rental

• Emergency assistance and travel-

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

Companies that provide selfless information through particip

elated services

• Emergency card replacement

• Travel accident insurance up to $100,00

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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