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Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...
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On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...
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Why search the scientific and medical literature?
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Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...
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Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...
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Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...
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Our previous update1, Analysis of China’s First National Tender on Coronary Stents, discussed the first national-level centralized tender for a...
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By Matt Gottschalk
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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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April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...
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In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...