“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”

The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.

US FDA Publication on Integrating Artificial Intelligence into Healthcare Product

On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.

Japan’s PMDA Remote Inspections

The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.

QMS Implementation for Class I Devices Under EU MDR

  OVERVIEW The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone […]