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Advice You - Emphasis and Your E-mail
I receive on average 8-10 e-mails each week asking if bolding or changing font 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 color to red is the same a yelling or screaming. Is it the same as using all ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in caps? It can be. Most who ask me these questions are trying to interpret wha lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. t the person who sent them an e-mail really meant. They aren't sure and don't here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe want to assume. But they know. Bolding and red type means the other side is d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro rying to make a point they don't want you to overlook! When you take the time 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 and make the extra effort to bold or change font colors on certain words or s 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 atements you are making an emphasis. Now, the tricky part is how is that emph nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically sis going to be perceived by the person(s) on the other side? That depends. 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 The very same e-mail sent to different people can garner different reactions b ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi sed on the relationship dynamics between you. The very same e-mail can be per ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a eived differently depending on how close you are or how well the person on the dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod other side knows you. That is because we all "read" things into e-mails -- t cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ings that are not there. We assume what they other side meant. That is very tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen angerous territory but everyone does it. So how do you avoid misunderstanding 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 s? Don't rely on formatting or caps to make your points. The English languag ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust in particular is filled with verbs and adjectives for every occasion. Bone u y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products and hone your written communication skills so that you can relay your intent . 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 and tone by choosing the appropriate words to do so. By making this extra effo elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip t, you can communicate with clarity and not leave any guess-work to formatting 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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