Top Industry News
- FDA Good ANDA Submission Practices Guidance for Industry
- EMEA Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
- FDA Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry
- EU publishes final arrangements for new IVDR transition in official journal
- FDA updated Guidance on Principles of Premarket Pathways for Combination Products
- MHRA Risk-Adapted Approach to clinical trials and Risk Assessments
- FDA Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
- FDA issues series of guidances under Drug Competition Action Plan