Top Industry News
- Public Hearing on the Draft of the Swissmedic eCTD v4.0 Implementation Guide
- SFDA- Guidance on Requirements for Medical Device Listing and Marketing Authorization
- Swissmedic- Optimization of the Labeling Phase for Human Medicinal Products
- FDA- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
- MHRA- Regulatory Status of Equipment Being Used to Help Prevent Coronavirus (COVID-19)
- Malaysia’s NPRA creates GMP Guidance for Traditional Medicine Manufacturers
- Health Canada’s Regulatory Response to COVID-19: Access to Health Products
- PMDA- Notifications and Administrative Notices: 3 guidelines (Exposure-Response Analysis of Drugs, Population Pharmacokinetic and Pharmacodynamic Analysis, and Quality and Safety of Gene Therapy Products)