MHRA-NICE Real-World Evidence Scientific Dialogue Opens to Medical Device Applications
The MHRA-NICE Real-World Evidence Scientific Dialogue will now accept applications relating to real-world evidence and medical devices, with Approved Bodies represented in relevant workshops.
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 New Guidance on Postapproval Pregnancy Safety Studies for Drugs and Biologics
The FDA has released new guidance on postapproval pregnancy safety studies for drugs and biologics, highlighting pregnancy registries, real-world evidence, and postmarketing surveillance expectations for manufacturers.