Guidance Library
Database across 50 global markets with PubMed, ClinicalTrials.gov and other research databases
Comprehensive FDA Guidance Documents
Real-time search across ALL FDA guidance documents for drugs, devices, and biologics
Found 2860 guidance documents
Last updated: 8/15/2026
Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff
Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff
Psychedelic Drugs: Considerations for Clinical Investigations
Psychedelic Drugs: Considerations for Clinical Investigations
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
FDA guidance document: Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
FDA guidance document: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Master Protocols for Drug and Biological Product Development
Master Protocols for Drug and Biological Product Development
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
FDA guidance document: Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
Forms FDA 3542a and FDA 3542: Questions and Answers
FDA guidance document: Forms FDA 3542a and FDA 3542: Questions and Answers
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
Certain Postapproval Requirements and Resources for ANDAs
FDA guidance document: Certain Postapproval Requirements and Resources for ANDAs
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry
FDA guidance document: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
FDA guidance document: Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
M15 General Principles for Model-Informed Drug Development
M15 General Principles for Model-Informed Drug Development