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Social Articles - Hanukkah, The Festival Of Rededication
Hanukkah is an eight day Jewish holiday and is being celebrated for eight days. This event 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 is celebrated on the 25th day of Kislev in late November or through the month of December. ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in If this event is celebrated at the end of December, then this event enters into the month of lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. January. During these holidays, the Jews celebrate it by kindling the lights throughout th here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe e nights of the festival. The lights are kindled according to the number of the day, such a d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro s one light the first day, two lights on the next and so on. The traditional story behind H 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 anukkah is that when Maccabees stood victorious over the Seleucid Empire, there was olive oi 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 l for only one day to light the eternal flame in the Temple but amazingly the fire burned fo nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically r consecutive eight days during which time new oil was prepared. Another understanding of t 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 he Hanukkah holidays is related to the story of Hannah and her seven sons. The story as tol ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi d in Talmud says that Hannah’s seven sons were tortured and slained when they refused to bow ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a to a statue and eat pork as per Antiochus’ policy and then Hannah committed suicide when sh dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod e heard that her sons are killed. In Hanukkah, the lights are lit about half an hour after cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin dark. The lights that are used can be candles or oil lamps, but there are places where elec tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen tric lights can be used such as hospitals where an open flame is not allowed. The Jewish ho 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 mes have a candelabrum in which one can place eight candles, as well as the shamash light. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust The blessings are then recited every night for eight days over the candles. The foods of ch y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products oice to celebrate Hanukkah include potato pancakes, and it is also preferred to eat fried fo . 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 ods, which are fried especially in olive oil. Hanukkah festival is an event that teaches us elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip to rededicate to our goals in life and thank God for the blessings he has bestowed upon us. 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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