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Search FDA Product-Specific Guidances

Search and read FDA Product-Specific Guidances records through the Assyro API: FDA's product-specific guidances for generic drugs: the bioequivalence studies…

GEThttps://api.assyro.com/v1/sources/fda-psg/search

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Search and read FDA Product-Specific Guidances records from your own code: FDA's product-specific guidances for generic drugs: the bioequivalence studies FDA recommends per active ingredient and reference listed drug, cited by ingredient, dosage form and date recommended. Published by U.S. Food and Drug Administration (www.accessdata.fda.gov/scripts/cder/psg); answered from Assyro's copy, refreshed daily 21:30 UTC.

Licence: public domain (see the terms). Each record links to its page at the source.

Example: "What bioequivalence studies does FDA recommend for generic apixaban tablets?"

Search

GET https://api.assyro.com/v1/sources/fda-psg/search with any of these query parameters. Repeat a parameter for a list (?phase=PHASE2&phase=PHASE3). An unknown parameter is refused by name.

Search parameters

  • ingredientstring

    The active ingredient, e.g. "apixaban" or "levothyroxine sodium".

  • rldstring

    A reference listed drug's NDA number, e.g. "202155".

  • querystring

    Words in the PSG, e.g. "fed bioequivalence" or "in vitro permeation test".

  • statusstring

    Only draft or only final PSGs. One of: draft, final.

  • includeUnlistedboolean

    Also return earlier PSG files the database no longer lists (mostly superseded versions); default false.

  • limitinteger

    PSGs to return, default 8.

  • offsetinteger

    Skip this many results (for paging), default 0.

Each result is a record; read one in full with Get a record.

What a record holds

  • id, title, url: the source's identifier, its title and its page at the source, to verify it.
  • authority, publishedDate, version: who published it, when, and the edition read.
  • snippet and fields: the matching text and the source's own fields.
  • asOf: the day Assyro's copy of the source was read.