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February 2024

Safety Observer 208

The FDA announced that FAERS started accepting postmarketing ICSRs in the E2B(R3) format.

Released 06-Feb-2024
Pages 40
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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.

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