A recent draft guidance reflects the agency’s views on when it may be appropriate to reduce the amount of safety information collected in late-stage and post-marketing studies and what types of data may be eligible for limited or non-collection.
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ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.
Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
