Years in the making, with dozens of experts and entities engaged in the back and forth discussions, the Alliance for Clinical Research Excellence and Safety (ACRES) just unveiled a global quality standard for clinical research sites aimed at raising the accuracy and integrity of data input from the very beginning of the process. Too often, […]
The National Institutes of Health (NIH) is lauding some successes in the early stages of its ambitious Precision Medicine Initiative, which is designed to leverage advances in genomics, in emerging methods for managing and analyzing large datasets while protecting privacy, and in health information technology to accelerate biomedical discoveries. As part of the initiative, NIH's […]
The U.S. Food and Drug Administration (FDA) hopes to “modernize and streamline” clinical investigations by promoting use of electronic health records (EHRs) in clinical trials with a new guidance providing direction on when and how to use EHRs as a data source in a trial, among other areas. The guidance is aimed at sponsors, clinical […]
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A new series of guidances from the U.S. Food and Drug Administration (FDA) proffer a number of goals, including articulation of the agency’s expectations regarding how sponsors should provide sufficient chemistry, manufacturing, and control (CMC) information to address safety issues in the nascent world of human gene therapy. Commissioner Scott Gottlieb said the agency plans […]
