FDA To Congress: Untitled Letters Not Used To Drive Market, Regulatory Policy

FDA rejected suggestions by lawmakers that the agency may be timing its publication of untitled letters describing inspection observations to affect the market or drive regulatory policy, writing to lawmakers that agency centers have different policies on which untitled letters are made public but in all cases their publication is merely used to communicate inspection observations that fall below the threshold of a warning letter. The letter offers further clarity into the approach FDA centers take in issuing untitled letters,...