Originally published April 2025.
Welcome to Insider issue #36.
Also, hello to the 267 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 special edition arrives at a pivotal moment for the life sciences industry. With substantial staff reductions at the FDA, new leadership at HHS and the agency itself, and ongoing regulatory enforcement against non-compliant manufacturers, companies face a complex landscape that demands both strategic planning and operational excellence.
In our first section, Jesse Hart examines the implications of the FDA’s downsizing and leadership transition, including Robert F. Kennedy Jr.’s appointment as HHS Secretary and Dr. Marty Makary’s confirmation as FDA Commissioner. His analysis moves beyond the headlines to offer practical guidance on strengthening your Quality Management System, optimizing regulatory submissions, and building risk management frameworks that account for potential delays.
Our second section features Leon Chagal’s breakdown of four recent FDA warning letters issued to pharmaceutical firms. From falsified temperature data to failed contract manufacturing oversight, these cases reveal the systemic failures—cultural, procedural, and technical—that continue to plague the industry. His recommendations provide a remediation roadmap applicable to any organization seeking to shore up its compliance posture.
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