Guidances directory

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All guidance documents2,854 total

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition LabelsGuidance Document · Human Foods Program
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for IndustryGuidance Document · Office of the Commissioner
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA StaffGuidance Document · Office of the Commissioner
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of SpecificationsGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Ingredients Declared as Evaporated Cane JuiceGuidance Document · Human Foods Program
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
Tobacco Product Master Files: Guidance for IndustryGuidance Document · Center for Tobacco Products
Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part IIGuidance Document · Human Foods Program
CPG Sec 540275 Crabmeat – Fresh and Frozen – Adulteration with Filth, Involving the Presence of Escherichia coliCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #231 Distributor Labeling for New Animal DrugsGuidance Document · Center for Veterinary Medicine
Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Exempt Infant Formula ProductionGuidance Document · Human Foods Program
Safety Considerations for Product Design to Minimize Medication Errors Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Contents of a Complete Submission for the Evaluation of Proprietary NamesGuidance Document · Center for Drug Evaluation and Research
CVM GFI #156 Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal DrugsGuidance Document · Center for Veterinary Medicine
CPG Sec 690150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent DiseasesCompliance Policy Guide (CPG) · Center for Veterinary Medicine
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #158 Use of Material from Deer and Elk in Animal FeedGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Acrylamide in FoodsGuidance Document · Human Foods Program
CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-FarmGuidance Document · Center for Veterinary Medicine
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid ActivityGuidance Document · Center for Drug Evaluation and Research
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory UseGuidance Document · Center for Drug Evaluation and Research
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content ClaimsSmall Entity Compliance Guide · Human Foods Program
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical InvestigationsGuidance Document · Center for Drug Evaluation and Research
Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #226 Target Animal Safety Data Presentation and Statistical AnalysisGuidance Document · Center for Veterinary Medicine
Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion AnimalsGuidance Document · Center for Veterinary Medicine
Certification Process of Designated Medical GasesGuidance Document · Center for Drug Evaluation and Research
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use —: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants: Guidance for IndustryGuidance Document · U.S. Department of Health and Human Services
Qualification of Biomarker — Galactomannan in studies of treatments of invasiveGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Questions and Answers on FDA’s Fortification PolicyGuidance Document · Human Foods Program
DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate RouteGuidance Document · Center for Drug Evaluation and Research
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E coli in CattleGuidance Document · Center for Veterinary Medicine
Integrated Summary of EffectivenessGuidance Document · Center for Drug Evaluation and Research
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Product Development Under the Animal RuleGuidance Document · Center for Drug Evaluation and Research
CPG Sec 100101 Crotalaria spp Seeds in GrainsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent: Guidance for Industry and Tobacco RetailersGuidance Document · Center for Tobacco Products
Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Nonclinical Evaluation of Endocrine-Related Drug ToxicityGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Colored Sea SaltGuidance Document · Human Foods Program
CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format RecommendationsGuidance Document · Center for Veterinary Medicine
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Uncomplicated Gonorrhea: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic DevicesGuidance Document · Center for Devices and Radiological Health
Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription DrugsGuidance Document · Center for Drug Evaluation and Research
Over-the-Counter Pediatric Oral Liquid Drug Products Containing AcetaminophenGuidance Document · Center for Drug Evaluation and Research
CVM GFI #220 Use of Nanomaterials in Food for AnimalsGuidance Document · Center for Veterinary Medicine
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal ProductsGuidance Document · Center for Veterinary Medicine
Analytical Procedures and Methods Validation for Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationGuidance Document · Human Foods Program
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Food Allergen Labeling Exemption Petitions and NotificationsGuidance Document · Human Foods Program
Naming of Drug Products Containing Salt Drug SubstancesGuidance Document · Center for Drug Evaluation and Research
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #218 Cell-Based Products for Animal UseGuidance Document · Center for Veterinary Medicine
CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive PetitionsGuidance Document · Center for Veterinary Medicine
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)Small Entity Compliance Guide · Center for Drug Evaluation and Research
Investigational New Drug Applications Prepared and Submitted by Sponsor-InvestigatorsGuidance Document · Center for Drug Evaluation and Research
Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Scientific Considerations in Demonstrating Biosimilarity to a Reference ProductGuidance Document · Center for Drug Evaluation and Research
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #211 Residual Solvents in Animal Drug Products Questions and AnswersGuidance Document · Center for Veterinary Medicine
Abuse-Deterrent Opioids-Evaluation and LabelingGuidance Document · Center for Drug Evaluation and Research
Critical Path Innovation MeetingsCenter for Drug Evaluation and Research
Electronic Submission of Lot Distribution Reports: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsGuidance Document · Human Foods Program
CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion StudiesGuidance Document · Center for Veterinary Medicine
CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal PeriodsGuidance Document · Center for Veterinary Medicine
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Alcoholism: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
S10 Photosafety Evaluation of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research