FDA Heard You, But Did They Really Hear You?

The FDA today posted a revised draft guidance (here)  on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II.  We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.

Many in the industry have complained that with the stated purpose of the PFC to identify all facilities used in the proposed application the Agency could determine whether a facility inspection was needed. 

First Month of GDUFA II Looks Good for Approvals

While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement.  It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs.  These numbers may go up a bit if some stragglers show up when the numbers are scrubbed for the official totals.

12