F.D.A. Posts Collection of Letters Outlining Concerns About New DrugsThe letters, many of which were already available online, detail why the regulators initially declined to approve some drugs. All eventually passed muster.
Source: F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs (https://www.nytimes.com/2025/07/10/health/fda-drugs-letters.html)