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Top Reference - Is It Real?
If any man be in Christ, he is a new creature: old things are passed away; behold, all thi 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 ngs are become new. --2 CORINTHIANS 5:17, KJV It may have happened to you at a Billy Gra ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ham Crusade. Perhaps it was during a telecast of The 700 Club or during a conversation wit lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. h a friend. Maybe you were alone with God when it happened. But some-how, someplace deep w here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ithin, you believed that Jesus of Nazareth, God’s Son, died for your sins and rose from th d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro e dead to be your Lord and Savior. Then that belief grew into action, and you called out, 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 “Jesus, I take You as my Savior. I surrender to You. Be the Lord of my life!” Then someth 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 ing wonderful happened. A deep peace came over you. No more internal fighting. No more run nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ning. Your sins were for-given. You were part of the family of God. It was as if you had b 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 een born all over again. Old things were gone; everything was new. For the first time, you ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi truly understood God’s love. But now some time has passed, and you’re wondering if anyth ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ing has changed. It is common for new Christians to wonder if anything actually happened w dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod hen they prayed. It seemed so wonderful, so easy—almost too good to be true—that many have cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin thought that maybe it wasn’t true at all. In a court of law, the truth of a matter is es tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen tablished by evidence. The statements of witnesses are accepted in court as valid evidence 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 . To prove the reality of your experience with Christ, God has given you three witnesses: ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust His Word, His Holy Spirit, and your changed life. As you examine the Word, as you receive y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products the assurance provided by the Holy Spirit, and as you look at the evidence of your new lif . 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 e, you will know that blessed assurance that Jesus is truly yours! SPREAD THE WORD THOUGH elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip T FOR THE DAY God gives us evidence that we truly know Him through His Son, Jesus Christ. 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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