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Top Industry News
- FDA Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
- SFDA The Data Requirements for Human Drugs Submission
- FDA ANDA Submissions – Prior Approval Supplements Under GDUFA
- PMDA Posts Guidance - Labeling of Codes on Containers to Identify Prescription Drugs
- EMA High-Quality Data to Empower Data-Driven Medicines Regulation in the European Union
- TGA Boundary and Combination Products Guidance - Medicines, Medical Devices, and Biologicals
- DKMA Switches to Quality Review of Documents Template, Ending Use of Special Danish Version
- PDMA GCP On-Site Inspection/Conformity Document Inspection for Medical Devices
- Team-NB Adopts Position Paper on Cybersecurity, Use of Off-Label Data for Medical Devices
- PDMA Revision of Package Inserts Based on Consultation on Revision of Package Inserts of Pharmaceuticals
- ICH Advances Guidelines on Selective Reporting of Safety Data, Viral Safety
- MHRA MORE Registrations - User Reference Guide
- MHRA Medicines: Apply for a Parallel Import Licence