I hasn’t been difficult to notice that a whole lot of biological new drug applications have been rejected in the last few years, many for CMC reasons. Recently CDER Director Patrizia Cavazzoni spoke on the matter at a recent at a Duke University and FDA event at the National Press Club iin the video above.
“Our standards have not changed. We have exactly the same standards as we had in 2018 and 2019,” she said, before going on to talk about how the quality related issues the FDA is seeing: contamination, overall oversight, manufacturing controls or insufficient quality management systems.
Max Van Tassell, a senior pharmaceutical quality assessor in CDER’s Office of Pharmaceutical Quality, provided insights from analyzing 100 complete response letters (CRLs) for Biologics License Applications (BLAs) issued between 2014 and 2024. He noted that facility-related deficiencies in CRLs typically stem from inadequate demonstration that proposed corrective and preventive actions would effectively mitigate risks identified during on-site inspections.
It should be a key takeaway from this presentation that:
- We aren’t doing enough risk management in the right ways.
- We treat our facility as a secondary consideration, especially in biosimilars.
- Companies do a really bad job building trust with health authorities.
Investigations of a Dog 