Safety Observer

October 2021

Safety Observer 182

Highlights include the new FDA draft guidance on safety reporting requirements for trial investigators.

Released 07-Oct-2021
Pages 19

Report 182 — Highlights

New FDA Draft Guidance

The FDA has produced a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials. The FDA has also published two additional draft documents on the use of RWE in regulatory decision making, and on the considerations that factor into FDA’s benefit-risk assessments.

New Malaysia GVP Guideline

The NPRA Malaysia has published the first edition of the Malaysian Guidelines on Good Pharmacovigilance Practices, which brings new PSMF requirements for Registration Holders.

EU Guidance on “Lay Summary”

The European Commission has published a new “Good Lay Summary Practice” Handbook to help produce summaries of clinical trial results in lay language, as required in the new EU Clinical Trial Regulation that will enter into force on 31-Jan-2022.

MHRA guidance on access to EHRs

The MHRA has published new guidance that describes the expectations regarding remote access to Electronic Health Records (EHRs) for Monitors and Auditors.

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