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  1. Guidance, Compliance, & Regulatory Information

Guidances | Drugs

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

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Cross-cutting guidances on topics that seek to modernize drug clinical trials and accelerate drug development

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