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Summary - Know your Man: Being Important
“…that is like putting on your own oxygen mask in the airplane before helping the children. You can’t 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 help anyone until you’ve helped yourself first.” ~ Anon A man is as important as anyone else. His d ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in sires, thoughts, opinions should count as much. He is also a spiritual being and deserves to be trea lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ted like God in a human outfit. This is where many men have problems. It seems they work at satisfyi here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe g their spouses and family, trying to make everyone happy, working hard to provide for them, postponi d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ng their life plans to fit the demands of their families, and so on. They forget they are important; 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 hey forget to put themselves first. In a recent survey when I asked what they would be willing to do 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 to please their mates, men responded that they would do anything. Anything! Well, this is the story. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically My cousin is a good example of this. In fact, I have thousands of good examples. My cousin: loving f 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 ather; attentive husband; good man. At the time when it was not customary for fathers to play with hi ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi children, he would. He worked hard to provide very well for his family. He was successful in his wor ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a k and very well respected. His wife was a great housekeeper, though probably not a good wife. In my o dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod inion, she was a little like I was: Bitchy, bitchy. When she mistreated his mother and his family; h cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin e supported her, though he was hurt. When she mistreated him; he never said a word. When she decided tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen o spend months in the country with her family, leaving him alone, he supported her. Everything she wa 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 nted, he gave to her.
Imagine how much pain he went through before he had the guts to tell the wif ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust he would go visit his mother, even when the wife was opposed to the idea. Does this man think he is y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products important? Not at all. How many men like that do you know? A Word of Advice: Ladies: Everyone is a . 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 hild of God and therefore important. Let’s give due to our fellow earthlings. Gents: Put yourself fi elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip rst. Pay yourself first. Everyone will thank you for this. You will feel important; they will know so 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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