Safety Observer 208
The FDA announced that FAERS started accepting postmarketing ICSRs in the E2B(R3) format.
Report 208 — Highlights
FDA & E2B(R3)
The FDA announced that FAERS started accepting electronic submissions of postmarketing ICSRs using the E2B(R3) standard on 16-Jan-2024, which marks the start of a two-year transition period.
FDA: Labeling for generics
The FDA has published the final guidance entitled “Revising ANDA Labeling Following Revision of the RLD Labeling”, which covers labeling updates for generics following revisions to the labeling of a reference listed drug (RLD).
Somalia: PV Guideline
The Somali Agency has published the First Edition of its Pharmacovigilance Guideline, which describes the ADR reporting requirements in the country.
SFDA PV Inspections
The Saudi Food & Drug Authority (SFDA) has published the annual report on Pharmacovigilance Inspections conducted in 2023 with information from the 22 inspections conducted over the year.
SO Service Update
The migration of clients and users to the new web-based Reading Platform is making progress: More than 60 clients are now using the platform, which combine more than 400 users.
