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.
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.
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.
Hot topics are taken from Safety Observer Lite May 2022