FDA Updates Guidance on Submitting Next-Generation Sequencing Data to the Division of Antivirals
FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.
MHRA Updates Guidance on Archiving and Retention of Clinical Trial Records
MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.
European Commission publishes EUDAMED Release Notes v2.25.2
The European Commission releases EUDAMED v2.25.2 with new validation rules, certificate controls, and API access. Key implications for medical device manufacturers.
Cybersecurity Becomes a GMP Priority Under the EU Cyber Resilience Act
The EU Cyber Resilience Act is reshaping GMP expectations for laboratories. Learn how cybersecurity, data integrity, and validation requirements will impact manufacturers.