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As it happens every few years, some zealous souls revive the controversy about the use and abuse of foreign languages in our country. They seem to forget that languages are indispensable links in our society and that they do not necessarily relegate nor pervert the use of our common language English

Let us go back for a minute to that day in Plymouth Rock

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

where the Mayflower has just anchored in the small bay. After fastening the rigging and checking the cargo lashes, the ship sits peacefully as if resting from the long crossing and no longer exposed to the battering of the waves and the disturbing creaking of the beams, the wooden grommets and the deck planks.

The executive officer knocks on Captain Chri

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

Examples of combination products may in

topher Jones' door and, after being told to enter, he stands at attention in front of the desk where the Captain is going over the meager inventory of their stores.

"Sir, I just came back from shore. All I found were some large and very strange black canaries with a red nightcap and a swinging nose that make the craziest noises. I also ran into some of th

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

natives who appeared quite friendly and by signs, offered us some tacos and enchiladas.."

"Tacos and enchiladas? Hey my name ain't Cort?s. Now what did the natives say?"

"Sorry sir, I could not understand a word they said and they did not understand anything I said. Maybe if you give me permission I can have little Freddie Bartholomew sit down with one

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

f their people and they can both learn our languages. Then, we can use them as interpreters.."

Captain Smith looked out the porthole toward the lush greenery that hugged the coastline and, all of a sudden, banged his fist on the table and roared:

"Absolutely not! I will not allow no foreign tongue aboard ship. For that matter not even offshore! The offic

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

Combination pro

al language is English! Tell the natives that they can come back to peddle their fettuccini when they can speak the King's English! And keep little Freddy Bartholomew away from the natives! You are dismissed."

Of course that was the end of the Mayflower and its merry Pilgrims. In minutes, the crew had filled the casks with sweet water, lifted the boats, r

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

ised anchors and turned into the wind for the long voyage home. No Thanksgiving. No Pocahontas and no Donald Trump. There was no settling of the new continent and, in due course, of course none of the great things that make this country great; things like the House of Representatives, the Senate, shrewd lobbyists, hot coffee lawsuits, American Idol, fat gi

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

ls college football, violent Hollywood movies and synthetic hamburgers.

Now seriously. This country had many native dialects before the Pilgrims arrived. The native Americans used more than 100 dialects and funny enough, there seemed to be a common language base to each dialect. They had no trouble communicating with each other as also their hand and sign

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

system allowed for immediate understanding. For long distances, they used their over- the- air smoke transmissions that worked fine, except in windy or rainy days.

The Spaniards who got here before the Pilgrims brought with them several Indo-European languages and dialects besides Spanish. Their ships were crewed by Spaniards of course, but also Portugues

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

, French, English, Normands, Waloons, Dutch, Welsch, Genoese, Valencians, Basques, Sicilians, Corsicans, Tunisians, and a few Moroccans. They all communicated in Spanish but among themselves - as recorded in the diaries of that time - they spoke their own languages. True linguistic democracy.

The natives of this new world, liberal-minded as they were, wan

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

ed to understand these smelly bearded dodos that had landed on their shores from those floating doghouses with the laundry hung on top. They were also anxious to learn more about the huge dogs the strangers rode and the reason they were all dressed like something out of OZ.

The natives did not waste time and set to learn the language of their visitors at

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

Following aspects would a

once. They also took pains to teach the Spaniards their own tongues. The visitors on their part, wanted to talk to the thousands of semi-dressed natives that they found everywhere so that they could sell them some decent clothes and, in the process, convince them that their God was better than their God.

Multilinguism has been with us since before the beg

dd to the challenges in developing combination products:

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

nning, so it does not make sense that after a few centuries, some misguided ignoramuses (can not find an appropriate label) perhaps influenced by recent Goebbelian demagogies, want to force English as the official language of the United States of America.

It is like insisting that cars should be driven on the roads and highways that cross the country. If

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

e think about it, we should ask: "What the hell is an official language?" Is it like the chronometers at the Olympic Games? That story about the official chronometer sounds ominous. It seems to imply that time measuring is the exclusive property of such and such brand name. Actually, there is no need to exclude anyone from keeping time. Just say - and in t

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

rms of commercial advertising it sounds better - that brand x has been selected as the official chronometer, or time measuring and recording (if you are fond of obvious euphemisms) instrument for the Games.

Same with the country's language. Everyone knows that English is the language spoken in theUnited States. If some states have a large percentage of Sp

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

nish-speaking citizens, it does not hurt a damn bit to go bilingual in some of the services provided by the state to its citizens. It is ridiculous to point out that having a few extra lines printed on public communications will wreck the state's financial health. In the end, those citizens that benefit from the extra lines are paying taxes the same as the

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

Professional from academic institutions, pharmaceutical industries, health care indust

rest of us.

It is clear that new citizens, legal and otherwise must learn English, and most of them do. The fact that some of the bi-lingual educational programs in some states become costly bureaucratic empires with no regard for the task they are supposed to perform, is another matter entirely. We all have read about the outrageous salaries and perks of

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

some of the administrators of these programs. We know about the extremely contradictory tendency that some schools have about their non-English speaking students remaining for years in classes where instruction is in their own language. These students, in this isolated environment are naturally prevented from learning English. The concept of "transition" i

.

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

totally prostituted in those cases. This transition was never designed to cover a long period of time; just long enough for non-English speaking children to get acquainted with their new environment. The efforts should be directed at rectifying the situations created by the bilingual policies and eliminating the abuses that are committed in its name.

But

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

Companies that provide selfless information through particip

let us go back to the Pilgrims. In the end, Captain Smith agreed to let some of his crew to learn the natives’ tongues and teach them English. In a few weeks they could communicate with each other. Once that first step was accomplished and there was a spirit of universal understanding, the good Pilgrims started to talk taxes. You know the rest of the story

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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