USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision