Most errors and technical failures in clinical trials arise due to the improper selection of clinical trial designs. The clinical trial design selection will also have a strong impact on the cost and time associated with clinical trials. The expected outcomes shall be thoughtfully addressed while designing a clinical trial and the selection of clinical […]

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Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully. Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear […]

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One of the most sought-after markets for medical devices in the world is the Australian market. With the regulatory reforms and an increase in demand for innovative products, the Australian medical device market is expected to be worth more than $4.56 billion by 2025 growing at a CAGR of 10%. There is a growing demand […]

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Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]

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In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare diseases, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions, and financial benefits, etc. These countries include the US, Europe, Japan, Australia, South Korea, and most recently, India. Incentives […]

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Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally? Numerous complementary medicines are recognized as premium brands in Australia and internationally. The obvious reason being – Australia’s complementary medicines industry is proudly backed by a regulatory regime that is regarded as one of the strictest in the world! With […]

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Australian regulators for registering do not distinguish between complementary medicines and other pharmaceuticals concerning the safety, efficacy, and quality of the product, including the imported ones! To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process. Read the first part of this series […]

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If you wish to market your vitamins, minerals, nutraceutical products, dietary supplements, and herbal products in the Australian market, it will be better to realize that the Australian regulatory requirements are quite different from other countries for such products. For example, in the United States of America (USA), such products can reach the pharmacy store, […]

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