Most errors and technical failures in clinical trials arise due to the improper selection of clinical trial designs. The clinical trial design selection will have a strong impact on the cost and time associated with clinical trials. The expected outcomes shall be thought and carefully addressed while designing a clinical trial. 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 expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing […]

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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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Regulatory agencies of various countries are providing benefits & regulatory incentives for orphan drugs such as faster approvals, fee concessions, and financial benefits, and many more. These incentives are to support and encourage pharma companies to work upon developing orphan drugs or medical devices for rare diseases. The countries that provide regulatory incentives include the […]

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Do you know? Internationally, the regulators consider Australian complementary medicines as the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines approval follows a strict regulatory regime and is one of the stringent in the world!. With such high quality of these products, the Australian complementary […]

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

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