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There’s a new job on the horizon. You get to leave your old job. You know, the one with the b

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

oss you can’t stand. The really mean one. The one you’d love to give a piece of your mind. M

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

Examples of combination products may in

tter of fact, you think you’ll do just that…before you leave….

It’s perfectly fine to act that

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

one out in fantasy, as many times as delights you. But heed this advice – don’t do it in reali

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

ty! And here’s why.

Life has a funny way of tossing curve balls our way. That very same ex-b

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

Combination pro

ss with whom you shared your parting piece of mind? Suddenly, he’s opposing counsel on a new c

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

se your new attorney boss just accepted. Even worse, he could be your attorney’s co-counsel on

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

a case!

Perish the thought, but what if for some unforeseen reason, your new job doesn’t work

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

out? Now you’re scrambling to interview elsewhere. You need a recent recommendation. It’s go

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

ng to be rather awkward to ask the one who vividly recalls you spouting off as you waltzed out

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

he door.

One certainly doesn’t have to lie when leaving an unpleasant position. “Thank you, M

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

Following aspects would a

r. Smith, it’s been great working with you. I couldn’t wait to get to work every day. I’ll mi

dd to the challenges in developing combination products:

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

s you.” That’s really piling it on, isn’t it? If that were true, why are you leaving?

If que

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

tioned as to why you’re leaving, choose a politically correct comment, such as: “I think my sk

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

ills are better suited to the new position,” or “The benefits are simply too good to pass up.”

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

Then, go the extra mile. Offer to train your replacement. Ensure the workload you’re leaving

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

Professional from academic institutions, pharmaceutical industries, health care indust

s manageable – complete tasks that may be difficult for the new employee to assume. Leave deta

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

iled notes regarding ongoing assignments, and an updated list of any deadlines or to-do’s for b

.

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

th your boss and your replacement.

The best way to leave a job, even a job for the boss you re

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

Companies that provide selfless information through particip

lly won’t miss, is with style and grace. Never burn bridges. You may have to cross them again

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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