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# CDER Planning 98 New, Revised Guidances for 2023
- URL: https://www.fdaweb.com/cder-planning-98-new-revised-guidances-for-2023/
- Published: 2023-02-01T12:00:00.000Z
- Updated: 2026-09-14T18:14:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153676

CDER has released its 2023 Guidance Agenda showing plans for 98 new and revised guidances in 18 categories. The categories, with the number of guidances [proposed](https://www.fda.gov/media/134778/download?ref=fdaweb.com) in each, are: Administrative/Procedural (17); Animal Rule (1); Biosimilars (1); Clinical/Antimicrobial (1); Clinical/Medical (17); Clinical Pharmacology (3); Compounding (6); Drug Development Tools (1); Drug Safety (3); Electronic Submissions (4); Generics (17); ICH (6); Labeling (3); Over-the-Counter Drugs (3); Pharmaceutical Quality/CGMP (1); Pharmaceutical Quality/CMC (10); Pharmacology/Toxicology (1); and Real-World Data/Real-World Evidence (3).