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When you were little, your parents probably tried to comfort you with those words. "It's okay. It'll be okay."

And you probably stopped believing them pretty

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

quickly, too. When your knees were scraped or the big kid down the street was picking on you, it wasn't okay, no matter what they said!

As adults, we

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

Examples of combination products may in

pend a lot of time thinking, "It's not okay." When you feel bad, physically or emotionally, you put a lot of effort into believing that you should feel

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

ifferent - better, happier, less demanding, whatever it may be. When you question your anger or sadness, or when you feel self-conscious or guilty about enjoyin

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

success, you're saying, "It's not okay."

What if your parents were right? What if how you feel - no matter what that feeling is, no matter how uncomfortable

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

Combination pro

r confused or conflicted you are - what if it's okay?

The reality is, you do feel like that, right at this minute. You do feel angry, or sad, or

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

self-conscious, or any of a thousand other emotions, some of which can be amazingly ambivalent. You do feel stress, or pain, or stiffness, or any of a t

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

housand other physical sensations - and they too can be ambivalent.

Denying your emotions and physical sensations is the equivalent of denying two thirds of wh

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

you are. If all you experience as "okay" is your intellect - your mental process and thoughts (and I'll bet you sometimes question how okay your thoughts are

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

s well) - you're only experiencing part of your life.

You may be asking, "But if I believe it's okay, how can I create change or do anything differently

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

"

You have to know where you are before you can get where you want to go. If you're on an eastbound highway in the United States, you're not going to reach th

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

Following aspects would a

Pacific Ocean, no matter how long you drive, unless you first accept which direction you're currently heading. Until you do that, you can't turn around and dri

dd to the challenges in developing combination products:

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

e west.

Likewise, if you're often impatient, you can't miraculously change just by denying your impatience. You have to accept the impatience - it's okay
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
> - so you can understand what causes it and explore ways to change.

Stop for a moment, right now, and think about how you feel.

How does your body fee
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
l, right now at this minute? What if it's okay for it to feel that way? What if it's perfectly okay to feel tension in your shoulders? What if it's okay to n
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
tice that you have a tiny bit of a headache?

And emotionally - what if it's okay to be irritated or annoyed? What if it's okay to be happy?

It's impossible t
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
take action when you're wrapped around the axle of fighting what's true. When you check in with yourself like this, really notice how you feel and acce
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t that it's okay to feel that way, you'll experience a spaciousness thatyou may find surprising. From that spaciousness, you can take action with renewed energ
.

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
and freedom.

I challenge you to take a moment at least once a day to check in with yourself. Experience how you feel - how all of you feels - and let
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
t be okay. You may be surprised!

"Our feelings are our most genuine path to knowledge." Audre Lorde, 1934 - 1992; American writer, poet, and activist.

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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