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FDA Issues New Flurry of Trial-Related Guidances

The U.S. Food and Drug Administration (FDA) has continued its torrid pace by releasing a slew of new clinical trial guidances over the past few weeks. New guidances include a revised draft guidance on Assessing Adhesion with Transdermal and Topical Delivery Systems [TDS] for ANDAs, which provides updated advice for the design and conduct of […]

ACRP Developing Competence Standards for PIs

ACRP Developing Competence Standards for PIs

The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles. "By developing and helping to implement this new PI initiative, ACRP and its partners are taking a major step forward to advance excellence in clinical […]