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Main Subject - Why I Started My Ezine
Why I started this E- Zine Sit back, and travel with me. I discovered 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 my need to write and gather inspiring stories about baseball as I drov ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in e on route 80 in Northern New Jersey in February 2004. I started thinki lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ng about the movies I have seen and the stories I have read that I love here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe d. Why did I like these stories? What was "My" definition of a great st d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ory? I was fixed on finding an answer. I started thinking about the mov 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 ie "Field of Dreams", one of my all time favorites. Why did I like this 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 corny movie so much? Was Field of Dreams a metaphor for living your f nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ield of dreams? Was creating a clearing done to allow the dreams to sho 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 w up? In the movie they cleared away a crop of corn to build a baseball ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi field. Do we need to clear away some of our own corn fields to see the ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a dreams that capture our hearts and then create a path to reach those d dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod reams? This movie has been an inspiration for me to pursue my baseball cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin dreams. Following my heart is what I love best about what I am doing. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen Field of Dreams is the only movie I have seen in my adult life ( tha 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 t’s if you consider me an adult)that I have been to the movie theater m ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ore than once to see. So I invite you to follow your passion. Whether y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products you are "The Rookie" or "The Natural" what are your "Field of Dreams?" . 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 Where can your passion reverberate for you? I feel so thankful that I elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip have been able to capture my dream at this time. I hope you do as well. 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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