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...
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rigbysampson
Aug 92 min read
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...
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rigbysampson
Jun 52 min read
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...
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rigbysampson
May 202 min read
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...
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rigbysampson
May 112 min read
Advancing Healthcare: EMA's Progressive Use of Real-World Evidence
As specialists in Real-World Evidence (RWE) at Nezar Consulting, we understand the critical role RWE plays in shaping modern healthcare...
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rigbysampson
Mar 112 min read
DARWIN EU®: Pioneering Real-World Data in European Healthcare
The European Union has embarked on a groundbreaking journey with the launch of DARWIN EU® (Data Analysis and Real World Interrogation...
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rigbysampson
Feb 283 min read
Empowering Clinical Development with Real-World Evidence: A Deep Dive from COG UK Congress
At the heart of the Clinical Outsourcing Group (COG) UK Congress, held in London in February 2024, was a session that not only captured...
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rigbysampson
Feb 142 min read
FDA Finalises Guidance on Charging for Investigational Drugs: What You Need to Know
The U.S. Food and Drug Administration (FDA) has recently finalised its guidance on charging for investigational drugs, marking a...
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rigbysampson
Jan 301 min read
Understanding the FDA's New Guidelines for Post-Approval Drug Safety - January 2024
In an important move to enhance public health, the FDA has released its final document on post-marketing safety surveillance of human...
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rigbysampson
Jan 182 min read
Understanding the FDA’s Final Guidance on Rare Disease Drug Development: Key Highlights
The FDA's final guidance on drug development for rare diseases, issued on December 26, 2023, marks a significant step in addressing the...
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rigbysampson
Jan 32 min read
MHRA's New Fast-Tracking Procedure: The International Recognition Procedure (IRP)
The International Recognition Procedure (IRP), introduced by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) from...
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rigbysampson
Dec 22, 20232 min read
FDA Finalises Two Real-World Data Guidances for Industry
The U.S. Food and Drug Administration (FDA) has recently finalised two critical guidances under the 21st Century Cures Act, enhancing the...
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rigbysampson
Nov 1, 20233 min read
Revolutionizing Clinical Trials: The Pivotal Role of Artificial Intelligence
In an era where medical innovation is the linchpin of healthcare advancement, the domain of clinical trials is witnessing a monumental...
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rigbysampson
Aug 29, 20232 min read
Fast-Tracking Hope: Navigating France's Early Access Program for New Medications
The pharmaceutical landscape is constantly evolving, bringing new treatments to the forefront that can potentially change patients'...
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rigbysampson
Aug 29, 20232 min read
The Intricacies of European Early Access Programs: Paving the Way for Future Drug Success
Europe, with its rich history of medical advancements, remains at the forefront of innovative drug development. One key mechanism that...
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