CDRH stands for Center for Devices and Radiological Health, an organization within the US Food and Drug Administration (FDA) responsible for regulating medical devices and radiation-emitting products. In the pharmaceutical industry, CDRH plays a critical role in ensuring that medical devices are safe and effective for patients. In this article, we will explore the meaning …
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CTMS stands for Clinical Trial Management System, a software solution used to manage and track clinical trials. In the pharmaceutical industry, clinical trials are essential for testing the safety and efficacy of new drugs and treatments before they are approved for use by patients. CTMS helps streamline the process of managing these trials, from planning …
CRISPR is an acronym that stands for Clustered Regularly Interspaced Short Palindromic Repeats, which refers to a DNA sequence found in bacteria and other microorganisms. This system was first discovered in the 1980s, but it wasn’t until the early 2000s that researchers began to fully understand its potential applications in genetic engineering and pharmaceuticals. Understanding …
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Developing and manufacturing drugs and medical devices is a complex and costly process. To help streamline this process, many companies turn to Contract Development and Manufacturing Organizations (CDMOs). In this article, we will explain what CDMOs are and how they are used in the pharmaceutical industry. What is a Contract Development and Manufacturing Organization (CDMO)? …
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In the pharmaceutical industry, there are a variety of agencies and organizations responsible for ensuring the safety and efficacy of drugs and medical devices. One such organization is the Center for Biologics Evaluation and Research (CBER). What is the Center for Biologics Evaluation and Research (CBER)? The Center for Biologics Evaluation and Research (CBER) is …
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The production of drugs and medicines is subject to strict regulatory requirements to ensure safety and efficacy. One such requirement is the creation and maintenance of Batch Production Records (BPRs). In this article, we will explain what BPRs are and how they are used in the pharmaceutical industry. What is a Batch Production Record (BPR)? …
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