Originally published July 2025.
Welcome to Insider issue #39.
Also, hello to the 411 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 significant developments across both the pharmaceutical and medical device sectors. ICH has released draft guidance M13B that could dramatically streamline how generic drug manufacturers prove bioequivalence across multiple dose strengths—potentially eliminating the need for costly human clinical studies for each strength. For medical device manufacturers, the FDA has finalized its updated Q-Submission Program guidance, consolidating previous documents and providing clearer pathways for early regulatory engagement.
Our warning letter analysis examines CTK OTC Laboratories, whose May 2025 citation reveals that the FDA is applying the same rigorous standards to OTC topical products as it does to sterile injectables—a wake-up call for manufacturers who may have assumed lower scrutiny for non-sterile products.
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