date:Feb 25, 2019
letters to human drug manufacturers regulated by the FDAs Center for Drug Evaluation and Research (CDER) have steadily increased over the past four years. In fact, in FY 2018, CDER issued nearly five times as many warning letters to human drug manufacturers as it did in FY 2015.
19 in FY 2015;
43 in FY 2016;
67 in FY 2017; and
94 in FY 2018.
But its important to note that we dont believe this reflects a growing problem in drug quality. On the contrary, the FDAs improvements to targeting inspec