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 1840 guidance documents
Last updated: 9/30/2026
Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
FDA guidance document: Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff
FDA guidance document: Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry
FDA guidance document: Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Evaluation of Therapeutic Equivalence
Evaluation of Therapeutic Equivalence
Potency Assessment of Active Immunotherapy Products
FDA guidance document: Potency Assessment of Active Immunotherapy Products
Frequently Asked Questions - Developing Potential Cellular and Gene Therapy Products: Guidance for Industry
Frequently Asked Questions - Developing Potential Cellular and Gene Therapy Products
Determining Whether to Submit an ANDA or a 505(b)(2) Application
FDA guidance document: Determining Whether to Submit an ANDA or a 505(b)(2) Application
Container Closure Systems for Human Drugs and Biological Products
FDA guidance document: Container Closure Systems for Human Drugs and Biological Products
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for Industry
FDA guidance document: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for Industry
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
FDA guidance document: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Draft Guidance for Industry, IRBs, and Clinical Investigators
Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration 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
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
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
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