> ## Content Index
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# CDER Plans 81 New, Revised Guidances in 2026
- URL: https://www.fdaweb.com/cder-plans-81-new-revised-guidances-in-2026/
- Published: 2026-02-25T12:00:00.000Z
- Updated: 2026-09-14T13:34:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160723

CDER has published a list of 81 new and revised guidances it plans to issue in this calendar year. The largest number of guidances in one category is 24 on aspects of generic drugs. The [guidance](http://www.fda.gov/media/185228/download?ref=fdaweb.com) categories and number of guidances in each category are:

- administrative/procedural (8)
- biosimilars (5)
- biostatistics/clinical/medical (2)
- clinical/medical (9)
- clinical pharmacology (4)
- compounding (8)
- drug safety (2)
- generics (24)
- International Council for Harmonization (3)
- Labeling (3)
- Pharmaceutical Quality CGMP (3)
- Pharmaceutical Quality CMC (10)