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Digg It - Gossip Can Bite
Did you ever work in a company, doctor’s office, hospital or anywhere that there are more than two people? Did you fin 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 d out the hard way that when a tongue starts wagging at co-workers your professional life will somehow suffer? Did you ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ever ask yourself how did this happen? When you only made one remark to Susie and now I am in a hot frying pan ready lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. o be eaten alive. Many years ago when I was younger and stupider I was working in a large hospital billing office. I here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe iked my job and interacted with all the employees in my department. I worked with this woman and we had a great work d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ng relationship. My job was to make her job easier and it worked. Then one day I was talking to another employee and 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 er name came up. I made one statement about this woman and believe me I wish I could take it back. At the time I was 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 peaking to my co-worker and I made this statement I did not think I had said anything out of the ordinary. But by the nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ime it had gone around the entire department and back to her I had an enemy for life. To be perfectly honest I do not 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 know what she thought I said because she never told me. I was even called into the manager’s office and asked what I h ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi d said to make the woman so upset. I truthfully told her I did not know. I told her what I had said to the other woma ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a n and I do not know what the out come was. The bottom line is I never knew what made my co-worker so mad, she would n dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod ver tell me. It made for a very unpleasant working situation. So I strongly suggest even though you have been told ov cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin r and over again if you do not want your private life hung on a clothes line at work for all to see, keep your mouth s tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ut. Always be very careful who you talk to at work, home or wherever. If you know from past experience that you can 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 ust this person, speak freely but if you do not know this person, speak cautiously. I sure learned that lesson the ha ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust d way. I suppose we all learn it the same way. I bet you could tell me stories about your work place or even in your p y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products rsonal life where one thing is said, passed on from person to person like a spreading fire and the next thing you know . 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 – it is the complete opposite of whatever was said in the first place. I hope you enjoyed my article. I hope you read elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip my other articles. I would love to hear from you. Just leave a comment on this article. Copyright 2006 Linda Meckle 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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