Safety Observer 205
Kenya updates guidelines describing Pharmacovigilance obligations of MAHs in the country.
Report 205 — Highlights
FDA Guidance on BRA
The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA’s regulatory decisions.
FDA Off-Label Guidance
The FDA has published a revised draft guidance for comments, which covers common questions regarding the communication of scientific information on unapproved use(s) of marketed products.
ePI Pilot in the EU
The EMA has announced that a first set of ePIs (electronic Product Information) has been published as part of the pilot project to test the use of ePI based on the Common Standard adopted in 2022.
New PV Guidelines in Kenya
The Pharmacy and Poisons Board of Kenya has published updates to the guidelines that describe the obligations of Marketing Authorisation Holders in the country.
Partner Audits Toolkit
The Pharmacovigilance Agreements Optimization (PVAO) Initiative of TransCelerate has produced a new toolkit that includes a suite of solutions to help with Marketing Partner Audits.
