Food and Drug Administration Advises Informal Merchandising Rule
June 29th, 2008
I’m not certain that one or two papers should serve to permit packaging for off-label use, but for certain one time a sure figure of papers are promulgated (not certain what number would work best) then perhaps the Food and Drug Administration could permit an “observational indication” position that could even be included in a “tentative” package insert (admitting any dose information, admonitions and guards specific to that use).