Guidances directory

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All guidance documents2,854 total

Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo.Center for Drug Evaluation and Research
Guía para la Industria: Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivoCenter for Drug Evaluation and Research
Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata.Center for Drug Evaluation and Research
Chapter 4 - Human DrugsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Chapter 3 - DevicesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Chapter 1 - GeneralCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 460.700 Controlled Release Dosage Form Drugs - Rate of Release of Active IngredientsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 420.500 Interference with Compendial TestsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 390.100 Definition of "Commerce" - 21 CFR 1000.3(d)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: Potency Assurance for Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Electronic Submission Template for Investigational Device Exemption (IDE) Applications: Draft Guidance for Sponsors and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval ManagementGuidance Document · Center for Biologics Evaluation and Research
Draft Guidance for Industry: US-Origin Statements on SeafoodGuidance Document · Human Foods Program
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children: Draft Guidance for IndustryGuidance Document · Human Foods Program
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Guidance for IndustryGuidance Document · Office of Inspections and Investigations
Regulatory Considerations for Prescription Drug Use-Related SoftwareGuidance Document · Center for Drug Evaluation and Research
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor VehicleGuidance Document · Center for Drug Evaluation and Research
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and InvestigatorsSmall Entity Compliance Guide · Center for Drug Evaluation and Research
Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDIGuidance Document · Human Foods Program
Draft Guidance for Industry: New Dietary Ingredient Notifications and Related IssuesGuidance Document · Human Foods Program
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Study Data Technical Conformance Guide - Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and RestaurantsGuidance Document · Human Foods Program
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards CompatibilityGuidance Document · Center for Drug Evaluation and Research
Enforcement Policy to Delay Requirements to Submit International Mail Tracking Number and Mail Service Name Until May 1, 2027: Guidance for Industry: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #298 (VICH GL62) – Target Animal Safety Evaluation for Veterinary Monoclonal Antibody ProductsGuidance Document · Center for Veterinary Medicine
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on DosingGuidance Document · Center for Drug Evaluation and Research
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff Guidance Document · Center for Devices and Radiological Health
Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered FacilitiesGuidance Document · Center for Veterinary Medicine
Potency Assessment of Active Immunotherapy ProductsGuidance Document · Center for Biologics Evaluation and Research
Container Closure Systems for Human Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut ProduceGuidance Document · Human Foods Program
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent PartsGuidance Document · Center for Drug Evaluation and Research
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
Submitting Next-Generation Sequencing Data to the Division of Antiviral ProductsGuidance Document · Center for Drug Evaluation and Research
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) TrialsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for CaprinesGuidance Document · Center for Veterinary Medicine
CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for OvinesGuidance Document · Center for Veterinary Medicine
CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for BovinesGuidance Document · Center for Veterinary Medicine
CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General RecommendationsGuidance Document · Center for Veterinary Medicine
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a DrugGuidance Document · Center for Drug Evaluation and Research
Forms FDA 3542a and FDA 3542: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Certain Postapproval Requirements and Resources for ANDAsGuidance Document · Center for Drug Evaluation and Research
M15 General Principles for Model-Informed Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome EditingGuidance Document · Center for Biologics Evaluation and Research
Statistical Approaches to Establishing BioequivalenceGuidance Document · Center for Drug Evaluation and Research
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
Q8, Q9, and Q10 Questions and Answers (R5)Guidance Document · Center for Drug Evaluation and Research
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft GuidanceGuidance Document · Office of the Commissioner
Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of ProteinGuidance Document · Human Foods Program
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology ConsiderationsGuidance Document · Center for Drug Evaluation and Research
Development of Non-Opioid Analgesics for Chronic PainGuidance Document · Center for Drug Evaluation and Research
Development of Non-Opioid Analgesics for Acute PainGuidance Document · Center for Drug Evaluation and Research
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Postapproval Pregnancy Safety Studies: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Pulmonary Tuberculosis: Developing Drugs for Treatment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket AuthorizationGuidance Document · Center for Tobacco Products
Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Submitting Continuous Glucose Monitoring Data in Clinical TrialsGuidance Document · Center for Biologics Evaluation and Research
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #91 (VICH GL8 (R)) Stability Testing for Medicated Premixes (Revision 1)Guidance Document · Center for Veterinary Medicine
Establishing Impurity Specifications for AntibioticsGuidance Document · Center for Drug Evaluation and Research
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation SequencingGuidance Document · Center for Biologics Evaluation and Research
Bioanalytical Method Validation for BiomarkersGuidance Document · Center for Drug Evaluation and Research
Study Data Technical Conformance Guide - Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP InspectionGuidance Document · Center for Drug Evaluation and Research
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety ReportsGuidance Document · Center for Drug Evaluation and Research
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of MedicinesGuidance Document · Center for Drug Evaluation and Research
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological CauseGuidance Document · Center for Biologics Evaluation and Research
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for IndustryGuidance Document · Human Foods Program
CVM GFI #273 Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
E22 General Considerations for Patient Preference StudiesGuidance Document · Center for Drug Evaluation and Research