Primary source: Inspections and Compliance
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Sign in to saveThe FDA is introducing a pilot program to expedite the Investigational New Drug (IND) application process, which will allow for rolling reviews of components during the pre-IND phase. This is a significant shift in how IND applications will be processed, with an aim to enhance efficiency and predictability.
This pilot is crucial as it represents a new pathway to reduce the timeline from drug identification to trial initiation, thereby promoting American leadership in medical innovation and ensuring faster patient access to new treatments.
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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.
