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Throughout the year our nation sets aside time for people to reflect upon our history, and to celebrate the momentous events and influential people who helped

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

shape America into what it is today - the land of the free, and a prosperous world power. February is often acknowledged as Black History Month, while March

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

Examples of combination products may in

for women's history. June, however, extends the celebration for African-Americans as Juneteenth is observed.

It may sound like a made-up number, but Juneteen

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

h actually dates as far back at the mid-nineteenth century, and rightfully so. Each year around the United States, Juneteenth celebrations mark the anniversar

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

y of the end of slavery in America - the emancipation of all African peoples brought to this growing country for labor and servitude. Normally celebrated on J

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

Combination pro

une 19th, Juneteenth festivities around the US - particularly the southern states - may last as long as week or even the whole month. Fourteen states have off

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

cially recognized Juneteenth as an official state holiday.

"Juneteenth" gets its name from a combination of the words "June" and "nineteenth," as derived fro

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

m that historical date in 1865. While the Emancipation Proclamation had been put into effect by President Lincoln two years prior, the Civil War still raged t

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

hrough the country, and the Rebel states which had seceded refused to acknowledge it. It took a bloody defeat by Union troops to secure the freedoms of those

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

f African descent, and on the Juneteenth date in 1865, Union General Gordon Granger personally saw to the release of slaves in Galveston Island in Texas. The

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

knowledge that they were finally free sent the now-former slaves into a frenzy of jubilation, and from this joy was born the first Juneteenth.

Since that tim

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

Following aspects would a

e, Juneteenth has grown into an annual commemoration of that day, culminating in activities to be enjoyed by all Americans. One might expect to enjoy a variet

dd to the challenges in developing combination products:

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

of ethnic foods at a Juneteenth festival, along with musical acts, games, and reenactments. Where Juneteenth is recognized as a state holiday, celebrations m

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

ight be sponsored by various cities, while other venues around the United States may hold smaller festivals.

Juneteenth, however, is more than an opportunity

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

to celebrate African-American culture. It is also a time of reflection and remembrance. Area churches and libraries may use this time to offer seminars and f

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

lms about this dark period in our nation's history, and pay tribute to those who did not live to see the first Juneteenth. Religious services may be held to h

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

Professional from academic institutions, pharmaceutical industries, health care indust

onor the pioneers who never gave up hope for freedom, and panel discussions may invite all to discuss ways to support African-American fellowship and business

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

. Juneteenth offers the opportunity to connect and strengthen the spirit.

If you are interested in participating in a Juneteenth event in your area, or perha

.

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

s organizing one if one has yet to happen, an quick Internet search on "Juneteenth" will lead to a wealth of information on Juneteenth traditions, possible to

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

Companies that provide selfless information through particip

pics for educational seminars, and recipes to serve. As always, remember those you celebrate, and seek to create a positive celebration for future generations

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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