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Actual - Annoying Government Regulations For The Fitness Enthusiast
For those of you who don't know, Malaysia has very, VERY tight regulations on sports suppl 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 ements and you are unable to purchase most of the new stuff that hit the shelves overseas ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ere in Malaysia. Maybe the US FDA is not good enough for some doctor that bums in the gove lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. rnment office I suppose? I'm not talking about steroids or anything illegal here. Not onl here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe that, if you were to attempt to get it shipped to you, it would be confiscated by the Mal d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ysian Customs. So we Malaysian fitness enthusiasts have to be content by just reading the 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 amazing product reviews and drooling at the ads in bodybuilding magazines. Anyway, 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 retty excited when my friend who is holidaying in Canada told me I could have my orders fr nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically om bodybuilding.com shipped to his place there and he could bring them back for me here in 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 Malaysia. I quickly browsed through the Bodybuilding.com 2005 award winners to quickly gau ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi e popularity and effectiveness, and decided on ordering the following (1 of each): 1. ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a Muscle Builder Of The Year - BSN NO-Xplode 2. Nitric Oxide Product Of The Year - BSN NO- dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod plode 3. Multi-Vitamin Of The Year - Universal Animal Pak Total cost is USD 100.8 cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin 7. Thats almost RM400. VERY cheap I would say. If these were sold here (we wish).. the cos tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen would easily exceed a thousand ringgit I bet (which up till today, I fail to understand). 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 With my shopping list all set, I decided to just read up on their shipping policy, and th ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ats when I came across this page - "y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products e/help/illegal.htm">What products are illegal in my country?". It basically says that . 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 the stuff I wish to ship to Canada, is considered illegal in their country. Darn... That elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ust ruined my day. Guess I wont be having the chance to try something new for the new year 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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