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
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.