MHRA aligns Declaration of Helsinki with UK Clinical Trial Regulations: What manufacturers need to know
MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.
FDA Finalizes Guidance on Sponsor Responsibilities for Safety Reporting in IND and BA/BE Studies
The FDA has finalized its 2025 guidance for sponsors on safety reporting in IND and BA/BE studies. Learn what manufacturers must update and how it affects your trials.