The US FDA gave its highest risk designation to Cook’s recall of its Fixed Core Wire Guide.

Carbogen Amcis, LGM Pharma, Vetter and PCI Pharma are focusing on expanding their businesses, while ChemWerth has filed its 500th drug master file for clevidipine with the FDA.

Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.