Primary source: Guidances | Drugs
Sponsors must respond to non-compliance letters within 45 days with reasons for delayed pediatric assessments and may request deferral extensions if applicable.
Failure to comply with PREA requirements can affect drug development and availability for pediatric populations. Sponsors need to ensure timely submissions to avoid regulatory actions.
Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.
The FDA is enforcing compliance with the Pediatric Research Equity Act (PREA) by issuing non-compliance letters to sponsors who have not submitted required pediatric assessments by their deadlines. The letters require sponsors to respond within 45 days, detailing reasons for delay and expected submission dates.
What changed: Sponsors must respond to non-compliance letters within 45 days with reasons for delayed pediatric assessments and may request deferral extensions if applicable.
Why it matters: Failure to comply with PREA requirements can affect drug development and availability for pediatric populations. Sponsors need to ensure timely submissions to avoid regulatory actions.
Practical implication: Review compliance with PREA obligations, prepare responses to any received non-compliance letters, and ensure any necessary deferral extension requests are properly submitted within the specified timeframe.
Published from the regulator source ingestion pipeline after PV impact triage.
Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.
Users must ensure systems remain connected to power, conduct proper startup procedures, perform preoperative checks, and have emergency ventilation plans in place. Acknowledgment of receipt of the safety notice is required within 30 days.
Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.
Users must perform a software update to disable remote control and speed regulation for e-motion systems before January 1, 2021, using the Mobility application (version V01.004). For newer models, users need to safely store QR code labels after pairing.
