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In the face of the bewildering and escalating dramatic crisis unfolding right before our eyes and shaking the continent, from Cape to Cairo and from Dakar to the

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

Horn of Africa, it is increasingly becoming untenable to continue to dwell on the sidelines of non-involvement while the gloomy destiny of the Continent is once

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

Examples of combination products may in

again hanging in a precarious balance.

The world has now fully recognized the global strategic importance of Africa as the Last Frontier in our cosmos with resp

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

ct to the countless unfathomable vital resources stored in her underground. This knowledge is indeed old hat to the developed world for centuries, as it was the

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

ery reason why colonial powers scrambled for Africa, ruthlessly engaging in conflict for control of land and resources, and competing for power and influence, fi

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

Combination pro

ally coming to a truce at the 1884/85 Berlin Conference when the region was divided up between contending parties. This historical flashback is imperative if at

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

all we are to contextualize and comprehend the contours and thrust of current events which are indicative of a recurring scenario, strongly reminiscent of those

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

ateful days of Western hegemony.

Driven by their selfish expansionist interests, nations from West and East, once again guided by their unquenchable thirst for

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

il and other vital minerals continue to meet their development needs at the expense of poor nations on the continent; and this, at any cost and by any means nec

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

ssary, often with poisoned gifts to their African lackeys or by fueling and fanning the ambers of conflict to push their pre-conceived agenda.

Paradoxically, pe

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

ple of African descent across the Diaspora are the missing element in this equation. As Africa’s legitimate heir they must be instrumental in developments and ha

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

Following aspects would a

ve their say in the shaping of the destiny of the region, perhaps even more than other stakeholders. African people can no longer afford to remain amorphous and

dd to the challenges in developing combination products:

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

ndifferent while Mother Africa, as a theater of externally orchestrated violent genocidal conflict, is being beset by epidemics, abject poverty, famine, ruthless

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

exploitation, and widespread destruction of vital infrastructure, causing massive population displacement and millions of refugees most of whom are children and

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

omen.

It is within this context that we are issuing this appeal to all Africans at home and abroad to pool our little pennies together and commit these funds to

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

the honorable and lofty cause of building a school infrastructure to educate our disinherited youth from a culture of dependency into one of self-help, unity, t

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

Professional from academic institutions, pharmaceutical industries, health care indust

olerance and self-determination. African-centered education, it is our conviction, is key to mental and economic emancipation. Never again should we remain idle

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

nd entrust our redemption on paternalistic promises of aids/donations (with strings attached) from any external party with hidden motives; let’s make it our busi

.

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

ess to fund our own. This prospect is measurable and attainable.

A visionary African American civil rights leader’s cogent remarks ought to be our food for thou

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

Companies that provide selfless information through particip

ht as he reminded that: ”Education is our passport to the future, for tomorrow belongs to those who prepare for it today.” Visit:http:/globalhandincorporated.or

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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