Welcome to Insider issue #54.
Also, hello to the 296 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, Jonathan Wacks opens with FDA’s final Q&A guidance on postapproval manufacturing changes to biosimilars and how to build comparability data a reviewer can follow quickly.
Dharmesh Patel covers the September draft guidance that would make eSTAR mandatory for original PMAs and most supplements, with a 15-day technical screening in place of refuse-to-accept review. Comments are open until November 17.
Jesse Hart closes with the warning letter to a maker of vertebral fracture assessment software. The FDA said three changes bundled into one release each needed a new 510(k) and asked the firm to stop distributing that version.
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