Guidances directory

All guidance documents2,828 total

• Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for IndustryGuidance Document · Office of the Commissioner
• Postoperative Nausea and Vomiting: Developing Drugs for PreventionGuidance Document · Center for Drug Evaluation and Research
• Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFAGuidance Document · Center for Drug Evaluation and Research
• Requests for Reconsideration at the Division Level Under GDUFAGuidance Document · Center for Drug Evaluation and Research
• Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat FoodGuidance Document · Center for Veterinary Medicine
• Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)Guidance Document · Center for Veterinary Medicine
• Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesGuidance Document · Center for Drug Evaluation and Research
• An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Small Entity Compliance Guide: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionSmall Entity Compliance Guide · Human Foods Program
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Conducting Clinical Trials With Decentralized ElementsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing StrategiesGuidance Document · Center for Veterinary Medicine
• Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development ProgramsGuidance Document · Office of the Commissioner
• Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Enforcement Policy for Required Warnings for Cigarette Packages and AdvertisementsGuidance Document · Center for Tobacco Products
• Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)Guidance Document · Center for Tobacco Products
• Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
• ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Control of Nitrosamine Impurities in Human Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Bioresearch Monitoring Technical Conformance GuideGuidance Document · Center for Drug Evaluation and Research
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and TerminologyGuidance Document · Center for Veterinary Medicine
• CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: MethodologyGuidance Document · Center for Veterinary Medicine
• Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2)Guidance Document · Human Foods Program
• Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases: Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
• Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• M12 Drug Interaction Studies: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• M12 Drug Interaction StudiesGuidance Document · Center for Drug Evaluation and Research
• FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Providing Over-the-Counter Monograph Submissions in Electronic FormatGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)Guidance Document · Center for Veterinary Medicine
• Container Closure System and Component Changes: Glass Vials and StoppersGuidance Document · Center for Drug Evaluation and Research
• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Pediatric Inflammatory Bowel Disease: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Application User Fees for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and OlderGuidance Document · Center for Drug Evaluation and Research
• Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination ProductsGuidance Document · Center for Drug Evaluation and Research
• Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of MedicinesGuidance Document · Center for Drug Evaluation and Research
• Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for IndustryGuidance Document · Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of the Commissioner,Office of Minority Health and Health Equity Office of the Commissioner,Office of Women's Health
• CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review ProcessGuidance Document · Center for Veterinary Medicine
• CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in DogsGuidance Document · Center for Veterinary Medicine
• Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated ArticlesGuidance Document · Center for Veterinary Medicine
• CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal UseGuidance Document · Center for Veterinary Medicine
• Considerations in Demonstrating Interchangeability With a Reference Product: UpdateGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally ActingGuidance Document · Center for Veterinary Medicine
• CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug ApplicationsGuidance Document · Center for Veterinary Medicine
• Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• Facility Readiness: Goal Date Decisions Under GDUFAGuidance Document · Center for Drug Evaluation and Research
• Diabetic Foot Infections: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research SubmissionsGuidance Document · Center for Biologics Evaluation and Research
• Platform Technology Designation Program for Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)Guidance Document · Center for Veterinary Medicine
• Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• REMS Logic Model: A Framework to Link Program Design With AssessmentGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #290 (VICH GL61) – Pharmaceutical DevelopmentGuidance Document · Center for Veterinary Medicine
• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based ApproachGuidance Document · Center for Veterinary Medicine
• Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical ProductsGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #120 Veterinary Feed Directive Regulation Questions and AnswersSmall Entity Compliance Guide · Center for Veterinary Medicine
• Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAsGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Revocation of Uses of Partially Hydrogenated Oils in FoodsSmall Entity Compliance Guide · Human Foods Program
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical ProductsGuidance Document · Center for Biologics Evaluation and Research
• Data Integrity for In Vivo Bioavailability and Bioequivalence StudiesGuidance Document · Center for Drug Evaluation and Research
• Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary SupplementsGuidance Document · Human Foods Program
• Draft Guidance for Industry: New Dietary Ingredient Notifications and Related IssuesGuidance Document · Human Foods Program
• Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAsGuidance Document · Center for Veterinary Medicine
• Controlled Correspondence Related to Generic Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
• Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health