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Jill Wechsler is ACT's Washington Correspondent

Articles

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

New Guidelines Aim to Advance Pediatric Drug Development

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

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

Report Admonishes EMA Efforts to Reform Trial Transparency 

Plan to keep new methods adopted during COVID in place.

FDA to Continue Inspection Efficiencies After Pandemic

EMA continues to familiarize industry with new clinical trial legislation.

Dragging the Clinical Trials Community into Conformity

‘Independence’ the priority for the longstanding European Organization for Research and Treatment of Cancer, Winette van der Graaf tells Applied Clinical Trials in interview.

Exclusive: Meet the New Head of Europe’s Formidable Cancer Non-Profit

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Congress Presses FDA on Key Policies and Operations

SVP, Clinical Pharmacology & Translational Medicine

Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.

With Project Optimus, Success Favors the Prepared

Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.

Europe Policy Leaders Recognize COVID-Driven Trial Benefits

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Clinical Trial Diversity Advances in Regulatory Agenda

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.