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First I will outline a brief history of the Passover festival.

Passover is the oldest and most important religious festival in the Judaism traditions, commemorating God's deliver

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

ance of the Hebrews from slavery in Egypt and His creation of the Israelite people. The Passover festival begins at sunset on the 14th of Nisan (usually in March or April) and mar

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

Examples of combination products may in

ks the beginning of seven day celebration that includes the Feast of Unleavened Bread. The focal point of Passover is a communal meal, called the Seder (which means "order,&q

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

uot; because of the fixed order of service), which is time of rejoicing and celebration at the deliverance for the Hebrews that God accomplished in the exodus.

Since its inceptio

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

Passover has traditionally been celebrated in the home with family and friends as they eat meal together. It has always been customary to invite guests to share the Seder meal, e

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

Combination pro

specially newcomers to the community. A Seder meal in most Jewish homes is an elaborate feast, with food, games for the children, and to tell the story of the Exodus from Egypt. I

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

t is not unusual for Seder to last several hours.

The Seder involves everyone present since they all share in this festival with reading and singing. While the father or grandfat

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

er is usually the leader of the service, others have roles as well. The mother of the home lights the festival candles that signal the beginning of Passover, the youngest child as

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

ks the four questions, the children help eliminate all Chametz, leaven, from the house, search for the hidden Afikomen (symbolic piece of Matzah, unleavened bread) and open the do

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

or for Elijah, the parents or the grandparents usually start to tell the story of the exodus, and various others are designated to read or lead certain portions of the service.

T

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

e term "Pasch", or the "Christian Passover" was named by early Jewish-Christians for Christians to distinguish their particular celebration of the Passover hol

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

Following aspects would a

iday from the "Passover" celebration of the Jewish people. Passover is really more than festival. It is a teaching experience, especially for the children, intended to

dd to the challenges in developing combination products:

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

call people to their identity as the People of God. The Passover Seder tells the story of God's grace in history and calls on all the participants to experience and share in the s

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

tory as their own story.

There has been increasing interest among Christians in this ancient festival. There are several reasons for this renewed interest, they are: an increasin

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

sensitivity to cultural and societal problems and corresponding desire to learn about others; renewed awareness of the importance of the Old Testament Scriptures as Christian Scr

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

ipture; the desire and need in our modern world to recover sense of the sacred through liturgy and sacrament, and the willingness to find new and innovative ways to worship. Most

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

Professional from academic institutions, pharmaceutical industries, health care indust

importantly, however, is the wonderful picture the Passover gives to believers of what Jesus Christ, our Passover Lamb has accomplished for us.

I would encourage Christian famili

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

s to begin a tradition of having a special Passover celebration. Children love this celebration and will look forward to it each year. It is a terrific teaching opportunity and he

.

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

lps us draw our focus toward the eternal significance of God's and Jesus Christ's passion. Good Friday would be the best day to consider, but anytime during the Easter season woul

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

Companies that provide selfless information through particip

d be appropriate. A Christian Passover celebration is really not difficult, but it does require some planning so it would be best to start your arrangements a few weeks in advance

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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