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From time to time my head fills with words that hang in there until I have written

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

them on paper. I call these Whispers. The Angels of Light Whisper came to me afte

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

Examples of combination products may in

the tragedy of the loss of life and destruction of the World Trade Center in New Y

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

ork City in 2001.

I sense this Whisper to be a call for each of us to assess our l

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

fe values and to set aside those values that sets one person or group against anoth

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

Combination pro

r person or group. We see examples of strife, greed, power plays, conflicts, and re

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

venges happening every day worldwide.

Is this Whisper a call for each of us to exa

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

ine our individual lives and discard those tendencies we have that plays into confl

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

cting ideologies?

Angels of Light

Brighten all earth shadows

Angels of Light

Em

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

erge

Angels of clear radiance

Open all portals

Of peaceful coexistence

Angels o

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

Light

Emerge

Angels of all radiant hues

Manifest greater understanding

Of eart

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

Following aspects would a

's vast plenties

Angels of Light

Emerge

All Beings of earth

Cast off shackles o

dd to the challenges in developing combination products:

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

f separation

Attune to your angelic nature

Angels of Light

Emerge

Angels garbed

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

in human form

From all boundaries break free

Anchored in fervent unity

Angels of

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

Light

Emerge

Angels of joy, love, compassion

Eliminate shadows that none may hid

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

e

To harm or deny another

Angels of Light

Emerge

Angels of cooperation

Release

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

Professional from academic institutions, pharmaceutical industries, health care indust

dominance, fear, aggression

In all its forms

Angels of Light

Emerge

Emerge Ange

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

.

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

Author's Note: This Whisper is not displaying correctly. There is a break afte

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

Companies that provide selfless information through particip

each Emerge and a break with the last line 'Emerge Angels of Light' standing alone

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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