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FDA: revised PSGs supersede older versions; no online archive for prior versions
Summary
FDA panelists said that when a PSG is revised the new version represents current agency thinking and older iterations are removed from online view to avoid confusion; FDA does not maintain an online archive of past PSG versions.
An attendee asked why historical product-specific guidances are removed after a new version is posted and whether prior versions are archived. Dr. Kotsabar explained that revised PSGs are intended to reflect "the current, agency's thinking" and keeping older versions accessible online could confuse applicants.
"So when we post revised PSGs, it's a new version of the guidance, and it's always going to be data to show, the current, agency's thinking on how to show a generic is therapeutic equivalent to the RLD," Dr. Kotsabar said. He added plainly that past PSG iterations are no longer considered valid once replaced and that "there's no archive of past, PSG versions online available."
The panel framed the practice as an agency judgment to minimize confusion rather than as a change in substantive review standards. Attendees who need historical context were not provided an alternate public archive at the session; the panel did not announce an alternate access pathway for prior versions.
