Guidances directory

All guidance documents2,320 total

• 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Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health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Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research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
• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested PartiesGuidance 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
• Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• 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
• 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
• Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• 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
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• 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
• Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Draft Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for IndustryGuidance Document · Center for Drug 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
• Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on DosingGuidance Document · Center for Drug Evaluation and Research
• Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug ProductsGuidance 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
• Early Alzheimer’s Disease: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Q14 Analytical Procedure DevelopmentGuidance Document · Center for Drug Evaluation and Research