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I've just returned from a 20-day vacation to Yosemite, Sequoia and Kings Canyon National Parks.

It's impossible to describe

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

the sheer terror of finally deciding to take more than a week's vacation. Would my business crumble? Would I miss logging

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

Examples of combination products may in

on each morning to get my email? Would my clients remember me when I returned?? Would I miss a new business opportunity whi

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

e I was gone?

It all started rather simply: three different opportunities for speaking engagements came up in California, a

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

d so close to one another that it seemed silly NOT to go to California and do presentations. My husband casually suggested,

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

Combination pro

"Why don't we both go, then take some time for a vacation while we're out there?" It seemed reasonable enough.

In the pas

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

, I'd take a week-long vacation a few times a year, and my business had survived. But 20 days away from my office? It took

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 bit of getting used to.

But let me tell you a secret: starting the very first day, I never once had a interest in finding

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

an internet caf? and checking my email. Not once did I feel like I had to pick up phone messages and return phone calls. I

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

t was shocking that I could so easily leave it all behind. It was heaven!

Vacations are mandatory for self-employed people.

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

When you do your annual budgeting for your business, schedule in enough revenue so that you can afford the cost of the vaca

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

Following aspects would a

ions as well as the cost of not earning money for the weeks you're away.

Why? Because we all need a break from our business

dd to the challenges in developing combination products:

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

s, from the high-energy involvement, from the stress, from the stuck places. You need time to pay attention to yourself, to

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

those you love, and to do the other things you enjoy. You need a place to clear your head and step away from the everyday b

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

sy-ness of your business.

After 20 days away, I'm refreshed. While hiking in Yosemite, I made some major strategy decisions

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

about the direction of my business for the next five years, without even really thinking about my business consciously. I a

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

Professional from academic institutions, pharmaceutical industries, health care indust

lowed my sub-conscious to process all the questions and decisions I had to make about my business, then allowed the answers

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

to slowly bubble to the surface while I walked, sat, talked, and took photos of lovely nature scenes.

Now that I’m back in

.

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

y office, I feel a rush of energy, and a great clarity of thinking. I'm also keeping in touch with the slow, calm, peaceful

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

Companies that provide selfless information through particip

feelings I felt each day I was away, and am bringing them back into my daily business life.

So, when is your next vacation?

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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