Top Industry News
- TGA- New guidance on electronic instructions for use (eIFU) for medical devices
- FDA advances three important initiatives to support medical device development, innovation and safety
- CDSCO- List of documents required for application for WHO-GMP/CoPP for ASU Herbal drugs-regarding
- FDA- Guidance Documents and MaPPs (PDUFA)- updated
- Health Canada- Changes to Evidence Requirements for Class II and Class III Infusion Pumps
- EMA- How are new medicines approved by EMA?
- TGA- Find out how the TGA regulates vitamins in Australia
- FDA- Export Certificates for Devices: FDA Issues Draft Guidance
- TGA- Application requirements for medical devices - preliminary assessment
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
- TGA- Comparable overseas regulators for medical device applications
- EMA Creates Simplified Transfer Process for Some MAHs Affected by Brexit