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Writer's block is a malady that afflicts hundreds of thousands of writers, worldwide.

S

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

uddenly, productivity plummets or stalls, and one’s mood tanks, as well.

Usually, it is

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

Examples of combination products may in

seen as a curse that no one would wish on himself.

But lately, I’ve been thinking write

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

’s block and most creative stoppages offer some bizarre satisfactions to sufferers.

Her

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

are five of them:

(1) Being a victim engenders sympathy from those around us. Periodic

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

Combination pro

ally, people can phone us and look into our soulful eyes and ask: “Have you been able to

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

write anything, lately?”

(2) A block is consistent with the stereotype that REAL artist

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

must suffer to birth their work. If it comes easily, it’s like cheating. Either we’re n

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

t genuine artists or what we’re churning out is less than good stuff.

(3) We have an ex

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

cuse for not producing. It’s like being possessed, homesteaded by an alien. “It’s not th

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

t I don’t want to produce,” we can maintain, “But this demon won’t let me!”

(4) We can

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

Following aspects would a

e openly jealous and critical of others who are more prolific. “Hey,” we can maintain, “

dd to the challenges in developing combination products:

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

f they suffered from this curse, they’d be just like me. Maybe they will, someday!”

(5)

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

It gives us an excuse to not look deeper into what’s really bugging us, like the multip

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

e rejections we have suffered at the hands of paste-eating magazine and book editors. We

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

don’t have to see that by becoming martyrs we’re really just projecting inward the great

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

Professional from academic institutions, pharmaceutical industries, health care indust

hostility we feel for others who don’t respect or pay enough for our work product.

As I

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

said in a recent article, writer’s block is a CHOICE. When we’re good and tired of it,

.

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

ecognizing it isn’t getting us to a positive place, we can inquire into why we have sele

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

Companies that provide selfless information through particip

ted this self-defeating behavior, and then get on with doing what we might actually love

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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