> ## 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.

# CDER Planning 85 New, Revised Guidances
- URL: https://www.fdaweb.com/cder-planning-85-new-revised-guidances/
- Published: 2026-07-16T12:00:00.000Z
- Updated: 2026-09-14T13:43:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161470

The latest iteration of the CDER Guidance Agenda projects that the Center will issue 85 new or revised guidances in CY 2026\. The [guidances](https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda?ref=fdaweb.com) are in these 14 categories:

- administrative/procedural (8 guidances)
- artificial intelligence (2)
- biosimilars (6)
- biostatistics/clinical/medical (2)
- clinical/medical (9)
- clinical pharmacology (5)
- compounding (8)
- drug safety (2)
- electronic submissions (1)
- generics (24)
- ICH (3)
- labeling (3)
- pharmaceutical quality (3)
- pharmaceutical quality/CMC (10)