FDA PSG

The FDA Product-Specific Guidances (PSG) resource is a public reference Database mAIntained by the U.S. Food and Drug Administration. It collects product-specific bioequivalence recommendations issued for abbreviated new drug APPlications and related regulatory work. Despite appearing in AI tool directories, this is a regulatory Information service rather than a Generative AI product; it is best treated as a specialized research resource for phArmaceutical development teams.

What it does

The service provIDEs a searchable index of guidance documents that describe recommended approaches for dEMOnstrating bioequivalence for particular drug products. Users can look up guidance by ACTive ingredient, dosage fORM, route of administration, or application-related criteria, then open the relevant recommendation document. The database reflects recommendations that may be updated over time as the agency revises its thinking, and entries can change without notice.

Key capabilities

• Search and filter functions for locating product-specific bioequivalence guidances by drug name and dosage form.
• Access to indiVidual guidance documents covering study design, in vitro Testing, and other bioequivalence considerations.
• Browsing by active ingredient to see whether a recommendation exists for a given product.
• Reference material aligned with generic drug submission and review processes.

Who it is for

The resource is aimed at generic drug developers, regulatory affairs specialists, formulation scientists, CLInical pharmacology teams, and consultants preparing abbreviated new drug applications. academic researchers studying bioequivalence methods and regulatory policy analysts may also find it useful. It is not designed for patients seeking treatment advice, and it does not replace formal regulatory consultation.

How to get started

Visit the FDA-hosted database through a Standard web browser. Use the search field to enter an active ingredient or select filters for dosage form and route. Review the listing of matching guidances, then open the document for the product of interest and confirm its revision date. Because recommendations are periodically revised, teams should verify they are reading the current veRSIon before relying on it in a submission.

Pricing and access caveat

Access is free and public, with no account required for bASIc use. Availability, document revisions, and interface details are controlled by the FDA and may vary; some documents may be witHDRawn or replaced. Users should confirm current guidance directly and treat this overview as informational only, not as legal or regulatory advice.