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Sign in to saveThe CDER SBIA has introduced new resources and events focused on compliance and submission updates, significantly impacting regulatory practices in drug development. Notable events include a workshop scheduled for September 29, 2026, addressing compliance and regulatory issues, and a virtual session on the FDA Bayesian draft guidance set for October 14, 2026.
These updates are vital for organizations navigating the complexities of drug development and regulatory submissions, ensuring that stakeholders are equipped with the latest compliance information and guidance.
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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.
