MHRA Outlines Data Requirements to Support Regulatory Decision-Making
The MHRA has published a paper on regulatory-grade data, real-world data and the data infrastructure needed to support safety surveillance and regulatory decision-making.
ICH Adopts E6(R3) Annex 2: New Global Guidance for Decentralised Trials, Digital Technologies and Real-World Data
ICH has adopted E6(R3) Annex 2, introducing new Good Clinical Practice guidance for decentralised clinical trials, digital health technologies and real-world data. Learn what it means for medical device manufacturers.
FDA Releases Draft Guidance on Bayesian Methodology in Clinical Trials – What It Means for Innovative Study Designs
FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.