Top Industry News
- FDA Providing Over-the-Counter Monograph Submissions in Electronic Format
- EMA Good Practice Guide for using Real-World Data (RWD) Metadata Catalog
- FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
- ANVISA Attention food industries: New Rules for Labeling Come into Force in 10 days
- Malaysia’s MDA Clarifies Postmarket Responsibilities in Update to Medical Device Guidance
- EMA Regulatory Information – Adjusted Fees for Pharmacovigilance Applications from 3 October 2022
- FDA Policy for Device Software Functions and Mobile Medical Applications
- Europe TEAM-NB Posts Position Paper on Hybrid Quality Management System Audits Under MDR
- India Posts Draft Rules on Registering Non-Sterile, non-Measuring Class a Medical Devices
- PDMA Generic Drug Quality Information
- FDA Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions