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Advice You - The Basic Human Equation
From my earliest days of childhood there has existed the notion that someday automation would make human beings obsolete. Computers have made millions of jobs extinct; companies with say thousands of employees would require a corresponding sized bookkeeping department. However with computer automation the number of employees has no relationship with the number of book keeping employees. John Deere for example has an engine 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 factory that is almost completely automated, a human programs the machine and loads the engine blocks onto the line. As the engine blocks move down the line the computer gives instructions and low paid humans visually inspect the machines performance for quality control, the humans have become the robots and the robots the workers. An American utility contractor working in Mexico explained to his Mexican foreman where they ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in needed a hole dug for the new sewer line. The next day the American found a gang of twenty laborers digging the required hole, incredulous he exclaimed get a backhoe out here and you can have that done in twenty minutes! The foreman explained that a backhoe would cost a hundred and fifty dollars and the laborers earned five dollars a day and without the work their families would go hungry. This is the crux of what we face lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. having the capability to do away with most of the labor force on the planet. Do we now spout slogans and jargon about being universally competitive? Do they move on to another planet to look for work? Are we no longer our brother’s keeper? From the dawn of time humans banded together in groups for their own survival and prosperity, this commitment predates writing. There are no founding documents or spoken covenant expres here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe sing this mutual contract it is part of our humanity, a component of who we are. As our societies advanced and we adopted rulers either because of their military prowess or organizational abilities, the mutual covenant arose. The leader or leaders would provide leadership and protection to their subjects and the subjects for their part would supply the labor or military service to the leadership. It was expressly a codepend d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ent relationship; neither side could or would prosper without the other. The initial unit of humanity the family that banded together with other families and through common cause then became our extended families. In my own childhood we would have people who would come to family functions the Dunmore’s asking my mother how they were related to us, she explained their Grandfather came to America with your Grandfather. Not f 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 amily but pseudo family but just the same we had common cause we struggled together. From genetic units to marriage connections to common cause we struggled together with the goal of survival and prosperity always mutually dependant on each other. For six thousand years the emphisis had been survival, regardless of government or religion climate or topography nothing changed the basic goal of society. Communities became co 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 untries that expanded our human families. Crafts and guilds were developed To advance the society, Pharaohs bought grain, not because they thought of financial gain But because it was there duty to do so. No one else had the resources; he was the leader who felt it necessary to protect his people from famine. Roman emperors passed out bread and cash to the poor not out of altruism but out of practical considerations. St nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically arving people committed crime and rioted; one serious fire would cost more than ten years bread. Was this civilization or the decline in civilization? The feeding of people not out of duty not because you owe them your concern as their leader but because it was cost effective? The Pilgrims with their Mayflower compact codified the no work no food ethic, whether this was out of any true concern for shiftlessness or more a p 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 art of their religious beliefs. For these were religious zealots who had been asked to leave two religiously tolerant countries. That being so, sailing across a treacherous ocean in a tiny vessel to an unknown wilderness one could hardly be expecting easy days and leisure time. Like their forbearers they mutually depended on each other for mere survival. Every Religion on the planet decrees as a central tenant that we must ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi care for each other and we are brothers and sisters in the religious family of man. Regardless of our personal beliefs whether we see this as God inspired or mere superstition, here it is again the founding principle of humanity the banding together for survival and prosperity in this world as well as in the next. Zealots and religious extremist use these doctrines to further their own political gains under the mantle of G ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ods will. They see the execution of the religion's doctrines as more important then perusing the founding tenants of the religion giving us martyrs, suicide bombers and kamikaze pilots. They genuinely believe that their religion or nation is under attack and that they are defending it. Trying to assure its survival in what they see as the only way possible. From Viking hordes to panzer blitzkriegs the soldier fighting agai dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod nst overwhelming odds and facing almost certain death fought for the survival of his family and land. Fighting for his family is universally obvious, but fighting for his land? For 98% of the population the land was his job no land no food no food no survival. We work to support our families and ourselves and we take pride in what our state or country produce. We identify with these things as a part our self worth, whether cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin it’s Mo town and we personally have nothing to do with the production of automobiles or the Peach state and we don’t personally grow any peaches. When the basic human covenant breaks down then who owes whom what? If for example a government shifts employment out of the country does the worker owe that society anything? Military service for example, during the Vietnam War college students were draft deferred leaving the wor tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen king class to shoulder the burden of military service. This was a violation of the basic covenant that the leaders or leadership class is codependent with the working class in military exercises. There are no exemptions in a situation of national survival. But what then do we owe to nationalism? If a nation takes no care for the safety and or successful employment of it’s people. This question has been answered a thousand t 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 imes throughout human history usually with a sword and the leaders head on a pike, No matter how technologically we advance nothing changes the basic equation The workers and the leaders are codependent both exist for the benefit of the other, Be it Kings Czars, Presidents or comrades, Pasha’s Sultans or Satraps. A country that doesn’t take care of its people is a country whose demise is on the horizon. Politicians out ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust of fear will pass repressive laws and jail thousands for they know that the basic formula for survival has been tampered with, they move to protect themselves and their class from those they should have been protecting in the first place. They will lash out and blame the worker but how can you blame those who are following you if we are lost! Laws are established to organize humanity when they are used to repress humanity t y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products he sum is always the same, sword and pike. What then what are we owed and what do we owe? We as a planet as a species have reached the point were a major percentage of the population is economically obsolete. We are pushing our environment to the brink by the exploitation of its resources and by our carelessness in doing so. Our leaders wish to govern by economic principles, how can we maximize profits? They know longer se . 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 e themselves as codependent with the workers they see themselves as the privileged class exempt and immune from the cares of the lowly. They deprecate our opinions what King upon hearing from a coastal farmer that Vikings had landed would have been so arrogant to have said, no their not! They have broken the basic human equation, that if a man doesn’t have a job and cannot support his family and if his government refuses t elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip o protect him from be it Vikings or global warming that country is doomed and it’s leadership is headed for the pike. That the worker owes nothing to a country that won’t defend him and will throw it down like a gun that doesn’t fire, as both are worthless. It matters not if you live in a penthouse or the White House or in a cave to export jobs is to import revolution this is not my opinion this is the basic human equation. 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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