Primary source: OCMO Guidance Documents
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Sign in to saveThe OCMO has provided a timeline for upcoming guidance documents, including a comment period for public input until June 8, 2026, affecting how regulatory practices may evolve.
This guidance agenda offers advanced insight into the FDA’s regulatory focus, allowing stakeholders to prepare for upcoming changes that may influence compliance and reporting obligations.
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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.
