Weekly Supplement: Week Ending March 15, 2024

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In the last Weekly Supplement, IPQ focused on the insights provided by FDA’s David Keire, who served as Regulatory Chair of the ICH Q2(R2)/Q14 Expert Working Group (EWG), on the just-released analytical procedure development and validation guidelines and how they support the advancing analytical technology. Keire provided the insights at the late-February ICH stakeholder consultation meeting co-sponsored by FDA and Health Canada (HC).

We are following up this week with a second presentation from the stakeholder meeting on another recently released ICH quality guideline, Q5A(R2), by HC’s Chris Storbeck, who served on the revision’s EWG, and is now on its Implementation Working Group (IWG). He addressed: ● the principles and objectives of and public comments on the revision of the viral safety evaluation guideline ● eight key updates in the revision, and ● Q5A(R2) implementation.

Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.

Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.

Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.