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  • Dataset id: fda_psg_guidance
  • Jurisdiction: US · FDA
  • Date field: date_recommended. The search’s top-level date_from and date_to filter on it.
  • Access: any API key.

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Filters

Send these under filters.fda_psg_guidance in a search request. A filter not listed here, or a value of the wrong type, is a 400. The top-level date_from and date_to set date_from and date_to below, so give a date in one place only.
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string
Keyword match on active ingredient(s) (BM25 tokenized, case-insensitive). Combination products list all ingredients, e.g. ‘Abacavir Sulfate; Dolutegravir Sodium; Lamivudine’.
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string
Keyword match on route of administration, e.g. ‘oral’, ‘ophthalmic’, ‘intravenous’, ‘transdermal’.
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string
Keyword match on dosage form, e.g. ‘tablet’, ‘capsule’, ‘extended release’, ‘suspension’.
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string
Exact match on guidance status: ‘draft’, ‘final’, or ‘withdrawn’ (delisted from FDA’s live PSG index).Values: draft, final, withdrawn.
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string
Reference-listed-drug (RLD/RS) application number, e.g. ‘020977’ (or ‘NDA 20977’ — digits are extracted and zero-padded to 6). Matches PSGs listing the number anywhere in their RLD set.
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string
Exact PSG identity — the PDF filename stem, e.g. ‘PSG_020977’, ‘PSG_021323-ODT’, ‘Acetaminophen_ERtab_19872_RC2-11’.
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string (date)
Inclusive lower bound on Date Recommended (YYYY-MM-DD). Moves forward on revision.
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string (date)
Inclusive upper bound on Date Recommended (YYYY-MM-DD).

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Fields

Each result from this dataset has these in fields: active_ingredient, date_recommended, dosage_form, guidance_status, psg_id, rld_app_number, rld_app_numbers, route, url