Welcome to Insider issue #49.
Also, hello to the 522 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. Read our past deep dives here.
This month, Jesse Hart breaks down CDER's draft guidance for new approach methodologies in drug development: the four-pillar framework, the validation-versus-qualification distinction, and where programs typically fall short. Jonathan Wacks explains the finalized Patient Preference Information guidance and how to structure a PPI initiative. And Judson Russell dissects the warning letter to PhysiTemp Instruments and what it teaches about 510(k) exemption claims, process validation, and complaint handling.
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