Originally published December 2025.
Welcome to Insider issue #44.
Also, hello to the 105 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This month brings guidance that could fundamentally change biosimilar development economics. FDA is acknowledging what the industry has long known: comparative efficacy studies often duplicate work that’s already been done. If you can demonstrate biosimilarity through analytical data and existing PK studies, you may not need to run another expensive clinical trial.
For medical device companies preparing for QMSR, there’s new draft guidance on what FDA expects to see in your pre-market submissions. The shift from document checks to system performance is real, and your submission needs to reflect it.
Our warning letter analysis covers Scientific Protein Laboratories—a case where equipment wear created metal particulate contamination, and pooled sampling practices hid potency variability in thyroid API batches until FDA found it.
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