FDA Pats FDA on the Back
Just in case you were wondering what the FDA thought of itself, worry no more. The agency thinks it’s doing just fine, thank you.
FDA just released its most recent annual report giving it a self-graded report card on whether it has hit its goals coming out of the 2007 MDUFA legislation.
In fact, just a glance at the report finds the phrase “meeting or exceeding performance goals/levels” popping up all over the place. My teacher used to give me smiley faces and gold stars.
At any rate, the FDA’s report card covers its new, improved review efforts through September 30, 2012.
“Overall the FDA has already met or exceeded, or has the potential to meet or exceed, based on preliminary data of completed and pending reviews, 23 of 27 Tier I performance goals, and 20 of 27 Tier 2 performance goals,” you’ll find in “FY 2012, Performance Report to Congress for the Medical Device User Fee Amendments of 2007.”
For those keeping score at home, Tier 1 targets focus on review speed, while Tier 2 covers overall completion of reviews.