Primary source: Inspections and Compliance
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Sign in to saveFDA's exercise of enforcement discretion will not initiate regulatory action for failure to comply with the 5-day, 30-day, or follow-up reporting timeframes for significant loss reports related to prescription drug samples following natural disasters.
This change acknowledges the challenges manufacturers and distributors face during emergencies, promotes compliance flexibility, and emphasizes the importance of timely loss reporting while maintaining regulatory integrity for thefts and diversions.
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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.
