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Advice Pool - Can You Write Love-letters?
Sometimes, even in this Electronic Age, we need to write (with a pen, on paper) to an absent loved one. Not everyone can be a 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 s poetic as a Robert Browning writing to his Elizabeth, but then, a letter of love is not always about romantic passion. It ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ight be a note to cheer close friends in times of sorrow or sickness. You might want to congratulate them on one of the grand lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. events of Life: a wedding, or the birth of a child. It could be to celebrate their success in some endeavor. Perhaps you hav here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe a much loved elderly aunt who needs to know she is still in your thoughts. Maybe you have relatives or friends serving in th d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro e Defence Forces, at a remote post or overseas. In any of these cases, when we sit down and write a letter to these folk, we 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 are expressing our love and our appreciation of them. No poetry can do that better than our own plain words written in simple 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 sincerity. It is the doing of it that counts. And it is the un-written letter that causes us the most regret. Too often, we nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ecide against writing to a favorite author, musician, film or sports star because we think: 'S/he is too famous to care about 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 a letter from an unknown person like me, must be far too busy to read all his/her fan-mail, anyway.' That kind of thinking o ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi erlooks the plain truth that even celebrities are only human like us. They need to know that they are connecting with their a ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a udience and are appreciated for what they do. Does it matter if we get no acknowledgment of the letter we sent to a famous p dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod rson? Not unless we are autograph hunters wanting to show off to our friends or make an easy dollar by selling the signed rep cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ly. We can be fairly sure our letter got delivered. Having written it, sending out thoughts of goodwill, is what really count tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen . Because of the work I do, a fair share of 'fan-mail' comes my way. It is always a thrill to hold in my hand a letter that 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 someone has taken the time to send, expressing appreciation of something I made - a book or a painting or an article on some ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ubject of interest to the sender. Today, such a letter has arrived from an eighty-five year old gentleman in England and it y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products has given me a big wake-up call. It has made me face the fact that the myriad creative people who have given me so much pleas . 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 re and enriched my inner life are on limited time. As are we all. One day, it will be too late for me to thank some of them i elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip n a letter. If there is someone you have been thinking of lately, why not write a note and send it off today? ©Dorothy Gauvi 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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