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Healthcare Essentials
June 12, 2023
New FDA Draft Guidance Updates Recommendations for Good Clinical Practices
The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from June 6, 2023.
The new guidance seeks to modernize the clinical trial process while safeguarding data integrity and participant safety by adopting International Council for Harmonisation’s (ICH) E6(R3) Good Clinical Practice draft guideline. The intent of the new guidance is to encourage innovation in generating reliable evidence more efficiently, thereby accelerating the patients’ access to new lifesaving products.
The new guidance recognizes the need to keep clinical trial conduct in line with advancing science and technological developments, noting that “innovative digital health technologies, such as wearables and sensors, may expand the possible approaches to trial conduct” and data collection. The guideline is media neutral to enable the use of different technologies for the purposes of documentation and encourages such technologies to be incorporated into existing healthcare infrastructures.
Nelson Mullins’ life science practice includes a team dedicated to working with Sponsors, Clinical Research Organizations (CROs), and Institutions to advance clinical research.
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