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

Articles

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

Hints on Looming Changes to European Clinical Trial Rules

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

UK Gov’t Offers a ‘Review’ Amid Clamor Over Declining Clinical Research

Jill Wechsler is ACT's Washington Correspondent

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Analysis: IRBs Need More Monitoring 

Probe targets agency’s role in advising on drug testing and submissions.

FDA Interactions With Industry Under the Microscope

Sanjay Shukla, MD, MS, CEO of aTyr Pharma, discusses the company's clinical operations and ongoing Phase III study for pulmonary sarcoidosis.

Maximizing Success in Rare Disease Studies

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

EU Seeking Wider Views in Its Push to Promote Clinical Trials

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Clinical Trial Diversity Continues to Face Challenges

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

FDA Food Center Reorganization Puts Field Inspections in Limbo

Craig Coleman, PharmD, Professor at the University of Connecticut, and the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) study's principal investigator discusses the ins and outs of the study. 

The OSCAR Study: Unlocking the Power of Real-World Evidence in Cancer-Associated Thrombosis

Vice President, Sites and Patients Center of Excellence, PPD Clinical Research, Themo Fisher Scientific

DCTs and RWD among topics for industry to focus on moving into 2023.

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