Featured in this Weekly Supplement are the results of an analysis by FDA of the deficiencies identified in the Complete Response Letters (CRs) issued on the Biological License Applications (BLAs) submitted to CDER over the past decade. CRs inform a sponsor of the issues that need to be corrected before an application can be approved. Emerging into relief were the frequency of facility deficiencies cited – with the percentage of those CRs containing them steadily increasing.
In focus are the insights provided by three CDER officials on the study outcomes at a Duke-Margolis-sponsored meeting on improving the CMC component of BLA submissions. Center Director Patrizia Cavazzoni provided an overview. OPQ’s Max Van Tassel and Brian Roelofs then focused in on the facility deficiencies identified in the CRs and the process control issues at play, respectively.
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.
