Resources for RA/QA/Clinical Teams: The FDA Group's Entire Premium Content Repository
Reporting CMC Post-Approval Changes, Proactively Addressing the Root Causes of Medical Device Recalls + Warning Letter Breakdown
Reviewing RMPs Against FDA's Drug Shortage Guidance, Inside FDA's Device VIP + Warning Letter Breakdown
Revisions to Q9(R1) Quality Risk Management, Getting "Recall Ready" + Warning Letter Breakdown
FDA Revives Its Proposed Quality Metrics for Pharma and Clarifies Device Cybersecurity Recommendations + Warning Letter Breakdown
FDA Resumes Inspections, But Keeps Remote Alternatives. Inside the Proposed Rule to Harmonize QSR and ISO 13485 + Warning Letter Breakdown
Free Sample Issue: Proposed CGMP Requirements for Compounding Facilities, SaaS & SaMD: Harmonizing QSR with IEC 62304 + Warning Letter Breakdown
Free Sample Issue: Another Take on FDA's Remote Inspection Authority for Devices, Updates to Software Documentation in Pre-Market Submissions + GMP Warning Letter Breakdown
Free Sample Issue: FDA Ramps Up Inspections, Enforces More from Inspection Alternatives, and Seeks to Extend Remote Review Authority to Medical Devices
