The US FDA recommends efficient clinical trial design strategies to expedite the development of oncology drugs and biologics. FDA also provides guidance and advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials. In contrast to traditional trial designs, where a single […]

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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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The Europe medical device market represents about 30% of the global market, after the U.S market with a 42% share. Rising geriatric population, an increasing number of surgical procedures (especially orthopedic), and the availability of funding for research and innovation are some of the driving factors for the growth of the medical device market in […]

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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 […]

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Any clinical research professionals and staff members say that one of their biggest challenges when conducting a clinical trial is, obtaining a sufficient number of participants.  If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study timeline, increasing resource usage and costs. A […]

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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 make 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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Financial benefits, faster approvals, and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for the development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil, and most recently, India. These incentives have been so supportive and convincingly […]

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Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]

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Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also gaining traction in rare diseases drug development.  Developing medicines or drug products in rare diseases is always challenging for both the scientific and clinical development team […]

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Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of the clinical segment. The global CRO market was estimated at $31.6 billion in 2018 and was expected to reach $45.2 billion by 2022, according to a report. What is a CRO? Contract research organizations (CRO) are the companies that provide support to […]

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