Articles

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.

Pharma Prices & Patents Under Attack

Medidata Launches Clinical Endpoint Adjudication System

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

The EU Cancer Research Summit sparked powerful support for personalized and precision medicine across three specific areas of research: translational, clinical, and outcomes.

Exploiting Research Infrastructures for Personalized Medicine in Europe

To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.

Thoughtful Design in eCOA Development: Part 1

Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management at Regeneron, discusses her experiences about how Regeneron rapidly and successfully developed a therapy to treat COVID-19. 

Inside Regeneron’s Monocolonal Antibody Development

Pressure mounts in Brussels as calls for new ways to debate pharma policies come from all directions.

New Structures to Tackle New Challenges in European Healthcare

Sponsors ignoring FDA requirements will now face stricter penalties.

FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results

White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.

Biden Seeks Added Funding for Medical Research, Disease Tracking

FDA officials have taken the unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility.

Blogs