Why FDA Says No

Every complete response letter FDA has published, one dot per letter, grouped by the kinds of section FDA wrote. 445 letters through Aug 7, 2026. Hover a dot for the drug; click to open its letters.

57% of readable letters cite only manufacturing

227 of 395 letters with readable section headings, 2009 to 2026.

227 Manufacturing onlyProduct quality, facility or CMC, nothing else

93 Manufacturing and evidenceBoth kinds of section in one letter

57 Evidence onlyClinical or nonclinical, no manufacturing

18 Other sectionsLabeling, REMS, human factors or device

50 No headings foundThe scan has no section headings we could read

Each letter is placed by the section headings FDA wrote in it: product quality, facility, microbiology or CMC count as manufacturing; clinical, statistical, safety and nonclinical count as evidence. FDA lists sections in a fixed order, so the first heading is not the main reason. A letter with both kinds sits in its own pile. openFDA complete response letters