Weekly Supplement: Week Ending May 3, 2024

To view the issue, please CLICK HERE.

Our last Weekly Supplement featured insights provided at the opening session of the April USP Workshop on Peptide and Oligonucleotide Therapeutics by CDER reviewer Lawrence Perez on the CMC challenges the agency is seeing in its review of synthetic oligos. In this Supplement, we focus on a complementary talk at the same session by CDER’s Katherine Duncan, in which she explored some of the key issues that need to be addressed in developing a control strategy for peptides.

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.