News & Updates
Stay informed about our latest activities, achievements, and developments
HACT Achieves Major Milestone with Dual Registration in USA and Ethiopia
Horn of African Clinical Trials (HACT) has been officially registered as a C-Corporation in Delaware, USA, and has begun formal registration in Ethiopia, strengthening its legal foundation and commitment to advancing clinical research capacity across the region.
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FDA Releases Draft E6(R3) Good Clinical Practice Guidance for Public Consultation
The FDA has endorsed the ICH E6(R3) draft guidance on Good Clinical Practice for public consultation, representing updated international standards for ensuring safe, effective, and high-quality clinical trial conduct and data integrity.
RegulatoryGCPFDA
FDA Issues Guidance on Enhancing Diversity in Clinical Trial Participation
The FDA has released comprehensive guidance addressing strategies to enhance the diversity of clinical trial populations, emphasizing the importance of representative participant enrollment to ensure that medical products are safe and effective across diverse demographic groups.
RegulatoryFDADiversity
New Study Reveals Geographic Distribution of FDA's GCP Inspections
A comprehensive analysis of FDA GCP inspections from 2016-2018 shows that 1,275 inspections were conducted across 347 marketing applications, with 63% of clinical investigator inspections performed in the U.S. and the remainder primarily in Europe, highlighting the need for expanded global inspection coverage.
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