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What do humans and the frilled lizard have in common? Well, when we’re afraid, we both puff out our faces and ears and try to act really, really scary. The

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

fear in jealousy is so strong that it can sometimes make us humans react to situations like a frilled lizard, just to make sure that our partner gets the po

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

Examples of combination products may in

nt that we don't want them to stray.

And how many times has that frilled lizard look ever made your beloved admire you more? Probably not many...

People us

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

the word ‘jealousy’ as a feeling, but Marshall Rosenberg, the creator of Nonviolent Communication (www.cnvc.org) would probably argue that it’s a thought.

F

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

r example, ‘abandoned’ is a thought -- it’s your negative evaluation of somebody leaving you. But what if they IRS abandoned you and your audit? Is that nec

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

Combination pro

ssarily negative? No.... so ‘abandoned’ is an evaluation of, or thought about, somebody leaving you.

In the same way, ‘jealousy’ isn’t really a feeling –

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

t’s a thought. The event may be your beloved paying attention to somebody else in a way that you think means s/he may leave you (or that they love another

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

erson more than you). It’s the meaning that we attach to the event that we label ‘jealousy.’

The true feeling underneath jealousy is usually fear--that your

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

beloved will leave you for another person. And fear is usually uncomfortable, if not down right painful. It awakens our limbic brain (the reptilian brain)

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

and puts us in a fight or flight mode. We yell, we threaten, we puff out our ears and try to look real scary and go, “Bwah! Bwah!!” And generally look re

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

l stupid.

So, when you feel triggered by the fear that underlies jealousy, it would help to call it what it is. Call it fear. Say to your partner: “Honey,

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

Following aspects would a

(Observation) “When I saw you talking to your ex this evening...

(Feelings) “I felt frightened...

(Needs) “Because I have a need for emotional safety in thi

dd to the challenges in developing combination products:

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

relationship.

(Request) “Would you be willing to tell me truthfully if you’re falling back in love with her?”

Those are the four steps to speaking honestl

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

using Nonviolent Communication. It’s scary to put your heart out to your beloved and expose yourself as being afraid. Most people don’t like to admit the

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

’re scared. But isn’t it a lot better than fighting like a frilled lizard with your lover? Asking the question in the nonviolent manner doesn’t imply that

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

your lover did anything wrong. You’re taking full responsibility for the feeling of fear, not blaming them for having done anything ‘bad.’

And, of course, t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is is just one way to ask one little question about your feelings of jealousy. It may be useful to sit and look at where in your life somebody did leave you

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

(or worse, didn’t love you but didn’t leave you, either). Those old wounds may be coming up now for you to look at, but your present lover may not be doing

.

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

nything out of line.

And always give your inner reptilian brain--your inner frilled lizard that puffs out its cheeks and tries to look scary--a lot of love.

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

Companies that provide selfless information through particip

You developed that response because at some time you had a beautiful need for safety in a relationship and your frilled lizard is just trying to protect you

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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