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One morning, earlier this spring I noticed there was a cactus growing in the woods

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

behind our home. Since I’m not particularly fond of cactuses (my preference is a

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

Examples of combination products may in

ot of bold colors year round in the garden, without thorns whenever possible), I d

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

idn’t think about it much.

I know cactuses have one of the prettiest blooms you c

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

n find in nature. But waiting for a single flower that opens for a few hours once

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

Combination pro

a year or once in decades is just not my thing. To be honest, the thought of remov

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

ng the cactus and planting something else in its place, did cross my mind…

I quic

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

kly forgot all about the prickly plant in my backyard being busy with making plans

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

about what and where to plant on our decent sized lot - until the crisp morning in

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

early April when I noticed the buds all over that same cactus plant.

Flower buds

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

never cease to enchant me and all of a sudden that unwanted plant became very prec

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

Following aspects would a

ous to me. I took photos and did some research. I found out that what I’m dealing

dd to the challenges in developing combination products:

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

with is a cactus, named Prickly Pear, Florida native plant which bears large, edib

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

e, fleshy and seeded fruits.

Now, that was enough information for me to become co

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

mpletely hooked! Ever since, I keep checking on my Prickly Pear a few times a day.

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

I keep taking photos and yesterday, about three weeks after I discovered the buds,

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

Professional from academic institutions, pharmaceutical industries, health care indust

the first bloom opened up in all of its glory. It was the prettiest yellow bloom

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

ver and I was thrilled.

There are still at least a dozen more buds on my prickly

.

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

plant and I can’t wait to see them all. However, as the first bloom closed up last

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

Companies that provide selfless information through particip

night, the second chapter of this story began. It has a title: From Bloom to Fruit

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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According to the Italian Tourism Board, there are about 40,000 hotels in Italy. That's a lot to choose from when you're traveling from overseas. Whether you're planning to stay in a hotel in Venice or a hotel in Rome, here's what you should know when you make your Italian hotel reservations.

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References - Florida Native Plants - Prickly Pear in My Backyard

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