Advice You - Business

I receive a lot of voice mail. Maybe you do, too.

Some folks leave nice

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

and clear messages that are easy to understand. Others seem to be in qu

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

Examples of combination products may in

ite a hurry, especially when they leave their phone number.

When return

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

ing calls, I make a point of praising those who leave clear messages. An

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

I encourage the others to speak a bit more slowly, cautioning that ‘hur

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

Combination pro

ried messages’ are sometimes difficult to decipher. Rarely do ‘fast spea

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

kers’ know about the problem. After all, who leaves themselves a message

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

on the voice mail?

Fax machines provide another opportunity to help eac

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

h other. Have you ever received a fax with a dark vertical line running

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 length of the page? This is caused by specks of dirt stuck to the gl

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

ss strip inside the sender’s fax machine. But the person who sends the f

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

Following aspects would a

ax never knows about the problem. They never see the lines. After all, w

dd to the challenges in developing combination products:

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

ho ever sends themselves a fax?

Whenever a fax with ‘long lines’ shows

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

up in our office, we make a point of contacting the sender, explaining h

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

w to open up the fax machine and quickly clean the glass.

It’s not real

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

ly our business, but then again, maybe it is.

Key Learning Point

All o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f us are partners with each other. If you help one person, maybe I will

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

et the benefit down the line. If I help another, one day you may reap th

.

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

e same reward.

Action Steps

Look for ways you can help others to impro

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

Companies that provide selfless information through particip

ve their service, accomplish their objectives, or simply do a better job

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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