FDA Draft Guidance on Additional Notifications Under Section 506J | FDA Source Cluster: Reg Desk Source Node: 3093775Time Stamp: Feb 1, 2024
MDCG Guidance on Clinical Evaluation: Specific Aspects | MDCG Source Cluster: Reg Desk Source Node: 3093777Time Stamp: Feb 1, 2024
FDA Draft Guidance on Third Party Review Program: FDA Expectations | FDA Source Cluster: Reg Desk Source Node: 3083152Time Stamp: Jan 23, 2024
TGA Guidance on Boundary and Combination Products: Boundary Products | TGA Source Cluster: Reg Desk Source Node: 3083154Time Stamp: Jan 23, 2024
MDCG Guidance on Clinical Investigation: Timelines | MDCG Source Cluster: Reg Desk Source Node: 3068527Time Stamp: Jan 18, 2024
FDA Draft Guidance on Third Party Review Program: Documentation and Reporting | United States Source Cluster: Reg Desk Source Node: 3068529Time Stamp: Jan 18, 2024
SAHPRA Guidelines on Establishment Licensing: General Questions | SAHPRA Source Cluster: Reg Desk Source Node: 3071325Time Stamp: Jan 18, 2024
SFDA Guidance on Product Classification: Specific Categories | SFDA Source Cluster: Reg Desk Source Node: 3071327Time Stamp: Jan 18, 2024
FDA Draft Guidance on Third Party Review Program: Process Highlights | FDA Source Cluster: Reg Desk Source Node: 3075260Time Stamp: Jan 18, 2024
SFDA Guidance on Product Classification: Introduction | SFDA Source Cluster: Reg Desk Source Node: 3075262Time Stamp: Jan 18, 2024
FDA Draft Guidance on Real-World Evidence: Specific Aspects | FDA Source Cluster: Reg Desk Source Node: 3078546Time Stamp: Jan 18, 2024
FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Special Considerations | FDA Source Cluster: Reg Desk Source Node: 3078548Time Stamp: Jan 18, 2024
FDA Guidance on Notifying on Discontinuance or Interruption: Conditions | FDA Source Cluster: Reg Desk Source Node: 3062595Time Stamp: Jan 15, 2024
BfArM Guidance on Fast-Track Process for Digital Health Applications: Fees and Glossary | BfArM Source Cluster: Reg Desk Source Node: 3062597Time Stamp: Jan 15, 2024
CHMP Q&A Document on Development and Assessment for Companion Diagnostic Products | CHMP Source Cluster: Reg Desk Source Node: 3043437Time Stamp: Jan 2, 2024
FDA Guidance on Discontinuance or Interruption Notification: Overview | United States Source Cluster: Reg Desk Source Node: 3038286Time Stamp: Dec 28, 2023
FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Factors, Goals, and Adequacy Assessment | FDA Source Cluster: Reg Desk Source Node: 3038289Time Stamp: Dec 28, 2023
SAHPRA Guidelines on Establishment Licensing: Costs, Documents, and Cooperation | SAHPRA Source Cluster: Reg Desk Source Node: 3038376Time Stamp: Dec 28, 2023
FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Credibility Evidence Part 2 | FDA Source Cluster: Reg Desk Source Node: 3038380Time Stamp: Dec 28, 2023
BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes | BfArM Source Cluster: Reg Desk Source Node: 3039357Time Stamp: Dec 28, 2023