Real World Evidence – Policy & Medicine

FDA Finalizes Guidance on Real World Evidence in Supporting Drug Approvals

Industry Calls for Further Clarity and Flexibility on RWD for Regulatory Decision-Making

RWD May Not Be Ready for Prime-Time Postapproval Confirmatory Clinical Trials of Therapeutic Agents

FDA Issues Two Draft Guidance Documents on Real-World Data

FDA Issues Draft Guidance on RWD Sourced from EHRs and Medical Claims Data

CDRH Report Provides Examples of Real-World Evidence in Medical Device Regulatory Decisions

Industry Reaction Mixed to FDA Draft Guidance on Real World Data and Evidence