Primary source: Inspections and Compliance
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Sign in to saveSponsors are now allowed to submit certain components of their IND applications on a rolling basis rather than waiting to submit a complete IND package. This includes responsibilities for submission through the ESG gateway and requirements for proposed submission timelines.
This initiative is designed to accelerate the path to IND submission and improve alignment between sponsors and the FDA. The change facilitates faster identification of potential issues, helping to avoid clinical holds and strengthen applications.
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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.
