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I Suggest - A Call to Action
"A parrot talks much but flies little."
— Wilbur Wright, American aviation pioneer On the one hand, some people who fail to grow the distance do 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 but don't think. They are like the hyperactive entrepreneur who burst into a travel agent's office and urgently demanded a ticket. "Where do you wa ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in t to go?" the agent asked him. "I don't care," he breathlessly retorted. "Just give me a ticket! I've got business everywhere!" On the other hand, lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. many unsuccessful people think but don't do. These people know all the theories. They can quote chapter, verse, phrase, and story from leadership here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe nd personal effectiveness books, magazines, and speakers. They are walking professors. But their experiences are all conceptual. They know, but don d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro t act on their knowledge. They are like an "expert" in love and marriage who has never had a date.
What Seeds are We Planting? A farmer prayed 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 ervently every night during harvest season for a fine crop. He pleaded for crops as fine as his neighbors. After one night of particularly strong l 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 menting and pleading, the Lord finally replied; "Ben," He exclaimed, "How can I give you a harvest? You didn't plant any seeds last spring." Now i nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically the time to prepare for our next harvest. We can't wait until harvest time to plant the seeds. We can't strike a bargain to plant seeds once we se 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 e whether the harvest is worth the effort. Harvest time will arrive whether we're ready or not. Now is the time to plant the seeds for the coming h ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi rvests. Now is the time for action. Now is the time to move from where we are to where we want to be. Now is the time to grow toward our distant d ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a eams. That takes courage and discipline. It's far easier to be a victim and use excuses like we're too old, it's too late, we've missed our big cha dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod nces in life, or today's opportunities aren't as good as they used to be. Such "Victimitis" leads straight to Pity City. If we're not careful, we' cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin l grow ever more bitter and resistant to change as we regret what might have been. If we've going to live to the fullest, we need to be thoroughly tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen sed up before we leave this earth. Countless people through the ages who awoke late in life have shown that it's never too late. There's still time 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 . If not now, when? Kerry was in her forties and slowly working her way toward a degree on a part-time basis. Many of her friends and family tried ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust to discourage her from "wasting her time." "You will be fifty by the time you finally get your degree," they told her. Kerry responded, "I wish I w y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products uld have completed my degree years ago. But since I am going to be fifty anyway, I want to have a degree when I get there." Perseverance Johann W . 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 olfgang von Goethe "We must not hope to be mowers, And to gather the ripe gold ears, Unless we have first been sowers, And watered the furrows elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ith tears. It is not just as we take it, This mystical world of ours, Life's field will yield as we make it, A harvest of thorns or of flowers. 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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