Primary source: Inspections and Compliance
Sign in with your work email to save this update, triage it, and track follow-up.
Sign in to saveThe pilot introduces a new rolling review process where the FDA will accept and review individual components of IND submissions as they are completed, rather than requiring a complete submission. This aims to improve efficiency in the IND application process.
By reducing the time to initiate IND-enabling activities and enhancing collaboration with QRIs, the pilot program seeks to facilitate faster first-in-human trials, addressing significant delays that can hinder drug development.
Sign in to unlock the full action card and owner assignment.
Sign in with your work email to read the full operational brief, action card, and evidence ledger.
Sign in with your work email to unlock the full briefing, regulatory action card, evidence ledger, and role-specific next steps.
PV teams should update workflows and SOPs to include the new section 19A approval processes and ensure compliance with the TGA's guidelines for managing medicine shortages.
PV teams should update their workflows regarding inspection readiness, review standard operating procedures (SOPs) to align with the new GCP inspection coordination processes, and ensure that all relevant personnel are trained on the updated guidance.
PV teams should review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.
PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.
