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The Cliffhanger

The Doubt Brought the End There is a story of a cliffhanger, det

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

ermined to reach the summit of a high mountain. After years of preparation, he be

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

Examples of combination products may in

gan his adventure. Only he journeyed alone, because he wanted all the glory. He b

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

egan his ascent, and as daylight faded he decided to continue climbing. Night fel

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

l. The Night fell heavy as he was overcome by total darkness. The Moonlight and S

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

Combination pro

tarlight were hidden within the clouds. There was zero visibility.

The cliffhang

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

er was only a few meters away from the summit when he slipped climbing a ridge an

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

fell off, falling at frightening speed. While falling he could only see shadow l

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

ike figures in the darkness and felt the tug of gravity sucking him down. In thos

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

e anguishing moments he saw his life pass before his eyes.

He thought death was

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

near when suddenly he felt the tightening of the rope around his waist that tied

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

Following aspects would a

him to a nail embedded in the rock of the wall of the mountain.In desperation, su

dd to the challenges in developing combination products:

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

spended in mid-air he looks up towards the sky and screams: "God, please help me!

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

"The unexpectedly a deep voice from the Heaven responds: "What would you have me

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

o?""Save me" "Do you really think I can save you?""Of course, God, you have the p

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

ower to help and save me""Well then, cut the rope" God said.There was a moment of

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

Professional from academic institutions, pharmaceutical industries, health care indust

silence, and then the man tightened the rope around his waist more securely.The

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

mountain rescue team tells of a story of a man they found frozen to death, his ha

.

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

nds wrapped firmly around a rope tied to its waist.......................... HANG

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

Companies that provide selfless information through particip

ING TWO FEET FROM THE GROUND!!! So ... how tight are your ropes? Would you let go

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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