> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Publishes 40 Product-Specific Guidances
- URL: https://www.fdaweb.com/fda-publishes-40-product-specific-guidances/
- Published: 2023-11-16T12:00:00.000Z
- Updated: 2026-09-14T14:16:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155807

FDA says it has published 40 product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The latest [batch](https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm?utm%5Fmedium=email&utm%5Fsource=govdelivery) includes 22 new and 18 revised PSGs, FDA says.

There are 30 PSGs for products with approved ANDAs, including 16 complex products. Some 22 of the PSGs (nine new and 13 revised) are for complex products.

“When finalized,” the agency says, “the guidances in today’s batch will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.”