The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance. The first month of official stats has not yet been available and it is almost December. I was curious about the delay, so I asked the CDER Press Office. Here is their reply:
“The Generic Drugs Program will continue to report monthly metrics under GDUFA III. The metrics are actively being pulled for the report. The Office of Generic Drugs suspects that the first few complete reports will take a little longer to post than in prior months due to report revisions and program enhancements triggered by GDUFA III. The first publication is expected in mid-December. “
I appreciate the Press Offices’ response and am glad I can pass this information onto our readers, as I am sure you are as anxious as I am to see what the beginning of GDUFA III is looking like. Hopefully, we will see both the October and November stats reported in mid-December. However, whenever they appear, we will be sure to get them to you as soon as they are available. We have conjectured about the delay in posting in other recent blogs and now we have our answer. Thanks for your patience and keep your eye on this page for the new posts.