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FDA Launches Rare Disease Innovation Hub: A New Era for Patient Outcomes
In a landmark move to address the complex challenges facing rare disease patients, the U.S. Food and Drug Administration (FDA) has...
rigbysampson
Aug 16, 20244 min read
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Real World Evidence: Transforming Drug Development and Regulatory Decision-Making
Real World Evidence (RWE) is rapidly emerging as a powerful tool to complement traditional clinical trials in drug development and...
rigbysampson
Aug 9, 20242 min read
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CIOMS Unveils Groundbreaking Consensus Report on Real-World Evidence and Its Impact on Regulatory Decision Making
The Council for International Organizations of Medical Sciences (CIOMS) has taken a significant step forward in shaping the future of...
rigbysampson
Jun 5, 20242 min read
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Streamlining Medicine Approvals in South Africa: SAHPRA’s New Guidelines Leveraging EMA Standards
The South African Healt h Products Regulatory Authority (SAHPRA) has introduced new guidelines to expedite the approval process for...
rigbysampson
May 20, 20242 min read
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