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Chinese Valentine’s Day is on the Seventh Day of the Seventh Month on the Chinese calendar, which falls

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

on August 4th this year. Legend has it that the seventh daughter of the Emperor of Heaven, a weaving m

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

Examples of combination products may in

id, fell in love and married a cowherd. They were so much in love that they forgot everything else in t

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

eir lives and didn't complete their farming and weaving duties, which angered the Jade Emperor. He exil

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

d them to opposite banks of the Silver River (Milky Way), and only allows them to meet each other once

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

Combination pro

year on the night of the seventh day of the seventh month.

This legend has been handed down for nearl

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

y two millennia. The Chinese people believe that the star, Vega, east of the Milky Way, is Zhi Nu, and

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

hat Altair, on the western side of the Milky Way is Niu Lang waiting for his wife.

The seventh day of

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

he seventh lunar month is the only Chinese festival devoted to love in the lunar calendar. Chinese Vale

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

tine’s Day traditions abound and this special day is celebrated differently depending on the Chinese pr

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

vince.

Some of the many traditions include Chinese girls preparing fruits, melons, and incense as offe

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

Following aspects would a

rings to Zhi Nu, the weaving maiden, praying to acquire high skills in needlecraft, as well as hoping t

dd to the challenges in developing combination products:

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

find satisfactory husbands. Girls place sewing needles on water. If the needle doesn’t sink, it’s a si

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

n of the girl’s maturity and intelligence and she is ready and eligible to find a husband.

People in s

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

me Chinese provinces believe that decorating the horns of oxen with flowers will save them from catastr

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

phe. Another tradition is for women to wash their hair to make it look fresh and shining.

On Chinese V

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

Professional from academic institutions, pharmaceutical industries, health care indust

alentine’s Day, young lovers go to the temple of the Matchmaker and pray for their love and happiness,

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

nd their possible marriage in China. In the evening, people sit outside to observe the stars. On this n

.

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

ght, Vega and Altair are closer together than at any other time of year. Chinese grannies say that if y

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

Companies that provide selfless information through particip

u stand under a grapevine, you can probably overhear what Zhi Nu and Niu Lang are saying to one another

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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