Topic

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

Articles

Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.

EFPIA: Trials Hampered by New Rules on In Vitro Diagnostics

Webcasts

Webinar Date/Time:
Session 1: Tuesday, April 18th, 2023 at 8am EDT | 1pm BST | 2pm CEST
Session 2: Tuesday, April 18th, 2023 at 2pm EDT | 11am PDT | 7pm BST

How to Use Hidden Data Flow to Accelerate Your Trials in an Inflation Reduction Act Environment

 enables universal access to clinical research for patients and providers by providing decentralized clinical trials through our platform and unified technology.

Webinar Date/Time: Wednesday, March 29th, 2023 at 11am | 8am PDT | 4pm BST | 5pm CEST

Virtual Sites—Are they the Future of RWE?

Jill Wechsler is ACT's Washington Correspondent

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Kudos and Hurdles in Tackling Rare Diseases

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

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

Analysis: IRBs Need More Monitoring 

Pandemic and supply shortage among factors in slow transition to new rules.

European Commission Adopts Proposal to Delay MDR Deadlines 

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

FDA Interactions With Industry Under the Microscope

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

Regulatory