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Our previous blog discussed the emerging trends for the companion diagnostics (CDx) regulations in China. There have been several developments since then, including the introduction of Laboratory-Developed Tests (LDTs) in China through pilot...
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Many articles discussing the difference between drug and device trials come from a regulatory perspective on how clinical trials are designed and...
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First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a...
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It goes without saying that the pandemic has disrupted all aspects of our lives especially the healthcare system, including the diagnostic industry....
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Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b, BA-BE...
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Companies preparing for an early phase study must deal with an array of challenges and decisions for biometrics, pharmacovigilance and regulatory...
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Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...
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In September 2021, China’s National Healthcare Security Administration (NHSA), the government agent in charge of publicly funded healthcare announced...
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Pharmaceutical manufacturers, medical device companies, and advanced diagnostic manufacturers are increasingly incorporating patients’ and providers’...
