Top Industry News
- FDA- ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
- Swissmedic- New system for issuing Export Certificates (FSC) and Manufacturing Certificates (MC) for medical devices
- EMA plans to deliver a Substance Management Service (SMS) and Product Management Service (PMS) to support EU-wide regulatory activities.
- FDA Issues Draft Labeling Guidance: Indications and Usage
- EMA- Pre-authorisation guidance (updated)
- SFDA- Data Requirements for Veterinary Medicinal Products
- EMA- EudraVigilance support guide (updated)
- MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018)
- EMA Supporting medicine developers