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A few years ago, I got into it with a guy from Missouri when I asserted that West Virginia was a “Yankee” state, des

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

pite the fact that it lies south of the Mason Dixon line. The reason? West Virginia was created specifically because

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

Examples of combination products may in

its residents did NOT want to align themselves with the Confederacy. The resulting discussion gave me a chance to a

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

ir my southern pride. Looking back a few years later, I think he equated that “Southerness” with racism and decided

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

he didn’t want to date such a person (there may be a few other factors, but that seemed to be the turning point).

W

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

Combination pro

hy is it that if someone raises a Southern flag they are automatically branded a racist? The reason is that most peo

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

ple associate the Civil War with slavery. The South (they reason) was created to keep people slaves, and so people w

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

o take pride in their Southerness must desire to reinstate slavery.

I won’t go into the history lesson, but I learn

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

ed in my middle-school history class that there were several causes for the Civil War; slavery was only one. In fact

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

, most northerners were as racist as their Southern counterparts, and Lincoln issued the Emancipation Proclamation p

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

rimarily to keep England out of the war.

The next thing folks think of while addressing us racist rednecks is the K

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

Following aspects would a

KK. Again, history is forgotten; the KKK originally set its sights on Yankee carpetbaggers who invaded the South to

dd to the challenges in developing combination products:

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

take advantage of the post-war economic plight. The racist slant evolved later.

I have been close friends throughou

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

t school and college with people from different backgrounds, and am a member of a church that has received its share

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

of persecution. I believe that everyone is of equal value and worth, and everyone has potential; too many people ign

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

ore that potential, but that’s another story.

I am Southern to the bone, a tried ‘n true GRIT (girl raised in the S

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

Professional from academic institutions, pharmaceutical industries, health care indust

outh), and I have the accent to prove it. I’m proud to be pre-Civil War Southern, since it shows my ancestors were i

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

ntelligent enough to have made the right decision about the North. I love the country and the wide open spaces, grew

.

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

up on horses, and dated more than one redneck.

Does that mean I think that people of any color or ethnicity are of

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

Companies that provide selfless information through particip

any less value than I am? Nope.

But I do find it interesting that folks prejudge me based on the red in my redneck

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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