Safety Observer

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May 2022

Safety Observer 189

The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports.

Released 09-May-2022
Pages 31

Report 189 — Highlights

FDA & E2B submissions

The US FDA has published the final guidance entitled “Providing Submissions in Electronic Format – Postmarketing Safety Reports”. The FDA also published updated guidance to help companies prepare their systems for the transition to the E2B(R3) format.

Canada: e-labelling

Health Canada has adopted interim implementation measures whereby companies can choose to use electronic platforms to complement physical labels for prescription medicines.

South Africa: PV Inspections

The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Inspections for Human Medicinal Products”.

Janssen COVID-19 Vaccine

The US FDA has announced its decision to limit the authorized use of the Janssen COVID-19 Vaccine to adults for whom no other COVID-19 vaccine can be used.

DILI e-learning

Following the publication of the consensus report on Drug-Induced Liver Injury (DILI) in September 2020, CIOMS and the UMC have produced the corresponding e-learning course.

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