Category: FDA

February 15, 2019 – Final Rule 503A Bulks List Dear Readers, This is not a full newsletter, but is merely to ensure you’ve heard that the 503A Bulks List came out today.  Here is a link to a PDF of the unpublished rule that I downloaded from the Federal Register:

CIRoA (2/4/2019), FOIA (2/4/2019), and ROFs (2/7/2019+2/11/2019) have all been updated since my most recent newsletter.  Additionally, there have been some related events that need our awareness. CIRoA The only changes to CIRoA since my last newsletter were these: The Fresenius Kabi Outsourcing Facility’s 483 after its initial FDA inspection (see details in FOIA below); …

The first government shutdown has ended (at least temporarily) and on their first day back, FDA staff added a small number of new actions to the CIRoA and to FOIA webpages.  I suspect these are actions that were in the wings when everything stopped in December.  There were a few actions posted just before the …