Top Industry News
- SFDA- Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards
- FDA- Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA
- MHRA- Guidance on Coronavirus (COVID-19) Tests and Testing Kits
- EMA Updates on Regulatory Expectations amid COVID-19
- Health Canada- Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot for Clinical Trials
- SFDA- Guidance on General Requirements for Medical Device Manufacturing
- MHRA Temporarily Eases GMP Rules
- Philippine FDA Starts Postmarket Validation of COVID-19 Antibody Tests
- FDA Clarifies Policies for Reviewing ANDA Amendments and Supplements
- ANVISA- Medical Devices: Changed Submission Regime
- Health Canada- COVID-19 – Regulatory Exceptions for Specific Medical Devices
- FDA- Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency
- MHRA- Medical Devices: EU regulations for MDR and IVDR (Updated)
- FDA- Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency