About FDA Guidances

Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.  Another method of obtaining guidance documents is through the Division of Drug Information.

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TOPICS Related to Drugs
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  • Advertising
  • Animal Rule
  • Biopharmaceutics
  • Biosimilars [Biosimilarity]
  • Biostatistics
  • Clinical/Antimicrobial
  • Clinical/Medical
  • Clinical Pharmacology
  • Combination Products
  • Compliance
  • Compounding
  • Drug Competition Action Plan
  • Drug Development Tools
  • Drug Safety [Safety – Issues, Errors, and Problems]
  • Electronic Submissions
  • FDAAA (Food and Drug Administration Amendments Act) [FDA Amendments Act) (FDAAA)]
  • Generics (Generic Drugs)
  • ICH-Efficacy
  • ICH-Multidisciplinary
  • ICH-Safety
  • ICH-Quality
  • Labeling
  • Modernization Act (Food and Drug Administration Modernization Act of 1997)
  • Over-the-Counter
  • Pharmaceutical Quality/CMC [Chemistry, Manufacturing, and Controls (CMC)]
  • Pharmaceutical Quality/Manufacturing Standards (CGMP) [Current Good Manufacturing Practice (CGMP)]
  • Pharmaceutical Quality/Microbiology [Microbiology]
  • Pharmacology/Toxicology [Pharm/Tox]
  • Procedural [Administrative/Procedural]
  • Product-Specific Guidances for Generic Drug Development (separate database)
  • Rare Diseases
  • Real World Data/Real World Evidence [Real World Data/Real World Evidence (RWD/RWE)]
  • User Fees

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