Safety Observer 212

CIOMS XIII: RWD & RWE

CIOMS has published a new report entitled: “Real-world data (RWD) and real-world evidence (RWE) in regulatory decision making”.

ICH draft M14: RWD

ICH has published the M14 draft Guideline entitled “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines”.

FDA REMS Logic Model

The FDA has published a new draft guidance for comments, which provides a systematic, structured approach to the design, implementation, and evaluation of a REMS.

Zimbabwe: PV Guideline

The Medicines Control Authority of Zimbabwe (MCAZ) has published a revised version of its “Pharmacovigilance Guideline for Pharmaceutical Industry”.