In a landmark move to address the complex challenges facing rare disease patients, the U.S. Food and Drug Administration (FDA) has...

Real World Evidence (RWE) is rapidly emerging as a powerful tool to complement traditional clinical trials in drug development and...

The Council for International Organizations of Medical Sciences (CIOMS) has taken a significant step forward in shaping the future of...

The South African Healt h Products Regulatory Authority (SAHPRA) has introduced new guidelines to expedite the approval process for...

As specialists in Real-World Evidence (RWE) at Nezar Consulting, we understand the critical role RWE plays in shaping modern healthcare...

The European Union has embarked on a groundbreaking journey with the launch of DARWIN EU® (Data Analysis and Real World Interrogation...

At the heart of the Clinical Outsourcing Group (COG) UK Congress, held in London in February 2024, was a session that not only captured...

The U.S. Food and Drug Administration (FDA) has recently finalised its guidance on charging for investigational drugs, marking a...

In an important move to enhance public health, the FDA has released its final document on post-marketing safety surveillance of human...

The FDA's final guidance on drug development for rare diseases, issued on December 26, 2023, marks a significant step in addressing the...

The International Recognition Procedure (IRP), introduced by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) from...

The U.S. Food and Drug Administration (FDA) has recently finalised two critical guidances under the 21st Century Cures Act, enhancing the...

In an era where medical innovation is the linchpin of healthcare advancement, the domain of clinical trials is witnessing a monumental...

The pharmaceutical landscape is constantly evolving, bringing new treatments to the forefront that can potentially change patients'...

Europe, with its rich history of medical advancements, remains at the forefront of innovative drug development. One key mechanism that...