> ## Content Index
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# CDER Considering 101 New and Revised Guidances
- URL: https://www.fdaweb.com/cder-considering-101-new-and-revised-guidances/
- Published: 2017-02-16T12:00:00.000Z
- Updated: 2026-09-14T22:07:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138001

CDER says that it is planning to publish in this calendar year 101 new and revised guidances in 16 categories. The updated guidance [agenda](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf?ref=fdaweb.com) lists these categories, with the number of guidances to be published: Advertising (1). Biopharmaceutics (3), Biosimilarity (2), Clinical/Antimicrobial (1), Clinical/Medical (11), Clinical Pharmacology (8), Clinical/Statistical (3), Drug Safety (3), Electronic Submissions (4). Generics (12), Labeling (6), Pharmaceutical Quality/CMC (11), Pharmaceutical Quality/Manufacturing Standards (CGMP) (4), Pharmacologyu/Toxicology (1), Procedural (29), and User Fees (2).