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

Articles

WHO in midst of forming group focused on developing guidance on best practices in clinical trials.

Jill Wechsler is ACT's Washington Correspondent

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

With compliance deadline at end of month, concerns over readiness remain.

Despite agreement on recommendations between European regulators, DCT unclarity remains.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation. 


Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.

Insights from second annual DTRA meeting indicate DCTs are here to stay.

Senior Director, LifeSphere Clinical at ArisGlobal

Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.

Vice President of Synchrogenix Regulatory Science, Certara

A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.

Summarizing important FDA and EMA revisions issued this year.