Thankfully, it looks like the FDA has been able to address its IT issues, although approvals are now appearing more than a few days after the approval letters are issued. This peek at the numbers is provided for approval information posted as of December 20th – which includes posted approvals through December 15th.

As of that date, the OGD has posted thirty-one full-approval actions and eight tentative-approval actions. Remember, not surprisingly, December has a lot of vacation time for Agency employees, but the totals thus far represent a good start for December!

We will keep you posted in early January regarding the full month’s approval actions on an unofficial basis. Have a great holiday season and a happy New Year!