Originally published September 2025.
Welcome to Insider issue #41.
Also, hello to the 312 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 a rare thing: the FDA making the business case for quality. The Office of Pharmaceutical Quality’s white paper on quality management initiatives takes an economic lens to something we usually discuss in purely regulatory terms—and the data is compelling. For medical device companies, especially smaller ones, the updated Small Business Determination guidance offers real runway extension through fee relief, but the timing requirements and affiliate traps can be brutal if you don’t plan ahead.
Our warning letter analysis covers Oasis Medical, a sterile ophthalmic manufacturer whose July 2025 citation contains language that should concern every sterile drug maker. When the FDA explicitly states that “reliance on visual inspection to remove defects from a process with low capability is unacceptable,” that’s a signal of evolving enforcement priorities.
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