Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.
Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.
A U.S.- EU confidentiality agreement, which was finalized in 2003, provides a legal basis for the two regulatory agencies to discuss clinical protocols and development programs for investigational products. So far, the two agencies have held eight meetings to discuss specific scientific issues raised by industry sponsors, explained EMEA Executive Director Thomas Lonngren, Pharm, MSc. Although FDA and EMEA officials issue separate letters presenting their views on the issue raised, there has been little disagreement between the two agencies so far, commented Murray Lumpkin, MD, MSc, FDA deputy commission for international and special programs.
He noted that this pilot advisory program is most suitable for resolving specific issues involving new technologies that lack extensive guidance or regulatory experience. The two regulatory agencies agreed at a March 2006 meeting in Brussels to continue the pilot while evaluating its value and future development. While these joint meetings are highly resource intensive, they would like to overcome an apparent reluctance of sponsors to seek advice on highly controversial issues.
— Jill Wechsler
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.