Suggest - Relationships

It’s amazing how many people continue to entertain the notion that we Black Americans are all alike. Instead of believing what their eyes see, and what their total life experie

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

nce clearly has taught them, many believe that we all think and behave the same. Whether this is a reflection of erroneous teaching passed down through generations, ignorance -

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

Examples of combination products may in

or both - the phenomenon intrigues me. So listen up... No, all of us don’t respond well to the accented greeting “What’s happenin’ brutha?” at the corner store – especiall

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

when we just heard you say “Hello, how are you today?” to the previous three non-Black customers. And no, we all don’t like chitlins. At least I don’t. I was a chitlin’ hater

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

before I ever saw one. Check this out...

I was 3, growing up in the projects of Portsmouth, Ohio. I walked over to my Grandma’s building (kids could walk around the neighbor

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

Combination pro

ood back then...) and, when I stopped at her door, I smelled something funky. Yeah, I thought I had boo-booed in my pants, so I checked. When Grandma came to the door, I immedi

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

ately said “Grandma I didn’t boo-boo!”, so I wouldn’t get a whuppin’. Instead, she looked at me kindly and said “Naw baby, it’s ok. That’s supper cooking.” And that was that.

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

Chitlins and me could NEVER be friends.

We Black folks are as different, within our race, as any other folk. We have our own individual opinions on every subject. We have dif

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

erent ways of doing things. We like different kinds of music. We don’t view politics the same.

Me and politics? Thanks for asking! I am all messed up, and I hate it. I am

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

either Democratic nor Republican. On the one hand, I can’t be a straight-up Democrat. I believe abortion is the murder of an innocent child, and I cannot condone it, under mo

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

t circumstances. I believe this nation will be severely judged by God for the millions of lives we have slaughtered in the name of convenience and choice. So the donkey platfo

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

Following aspects would a

rm is shaky. That’s my opinion. On the other hand, I certainly can’t be a card-carrying Republican, either. Take away affirmative action and that’ll level the playing field..

dd to the challenges in developing combination products:

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

please. Until the hearts of all men are pure, and true justice reigns (not happenin’ today!) we must maintain federal and state programs just to stay on the field. And there

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

are, of course, many other cons and pros.

What I’m trying to say is this: I am a man first, just me. I am a Black man second. Yes, we Black men and women have some collectiv

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

concerns, a certain amount of shared pathos , arising from our shared painful past which we are daily changing to a triumphant future - but we are each something more fundamen

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

al than a cog in a Great Black Cause. I am, like you - just me.

Let me just speak for myself. (Insert deep breath sound here:)

When it really comes down to it, I am just a

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

Professional from academic institutions, pharmaceutical industries, health care indust

dude trying to get as close to God as I can, work an honest day and live an honest life, prepare my children to be smarter and better and stronger and richer and more godly tha

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

I am, be a general blessing to my fellow man, stay out of jail and not go to hell when I finally die - hopefully with some honor, a long time from now.

.

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

(exhale here)

Yeah, you probably think this way, too. Whom ever you are... In this way, I guess we Blacks aren’t the only ones who a

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

Companies that provide selfless information through particip

e just alike. We are ALL pretty much alike when it comes right down to it, aren’t we?

Just remember one thing: You may - and it's cool - but I ain’t eating no chitlins... BK

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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