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

Articles

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

Europe’s Regulators Plan Real Action on Exploiting Real-World Evidence

Jill Wechsler is ACT's Washington Correspondent

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Top Priority for Califf is Combating Health Misinformation 

Industry Leader, TCS ADD™ Supply Management

Recent updates from regulatory bodies are providing more confidence in integrating different forms of trials and technology.

Evaluating Global Regulatory Landscape for Driving Digital Innovation in Supply Management

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

FDA Confirms Ongoing Reliance on Remote Inspection Methods 

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.

Another Battleground Takes Shape in Europe: Real-World Evidence

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

FDA Continues to Grapple with Accelerated Approval Issues

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Gamesmanship Escalates Over FDA User Fee Legislation

Payers join the push for better demonstrations of efficacy of new medicines.

More European Big Hitters Demanding Drug Evidence Evolution 

Sirj Goswami, PhD, CEO, co-founder of InsightRX

Vice president of Global Biopharma Strategy

Understanding Project Optimus

Largely discarded topic beginning to grab hold in policy discussions. 