On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions.  The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.”  This guidance document supersedes “Requests for Feedback on Medical Device Submissions: Pre-Submission Program and Meetings with FDA and Staff.”

So,

The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here),  83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions.  This is the first time this FY that the total has fallen below 100 approval actions in a single month.

We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.”  While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a tougher enforcement stance from the Agency.

In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93).  While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach,