Guidances directory

All guidance documents2,828 total

• CVM GFI #135 Validation of Analytical Procedures for Type C Medicated FeedsGuidance Document · Center for Veterinary Medicine
• Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 104030)Guidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport VehiclesGuidance Document · Human Foods Program
• S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic DrugsGuidance Document · Center for Drug Evaluation and Research
• Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and CiderIndustry Letter · Human Foods Program
• Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• How to Comply with the Pediatric Research Equity ActGuidance Document · Center for Drug Evaluation and Research
• M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug DictionariesGuidance Document · Center for Drug Evaluation and Research
• Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy VolunteersCenter for Drug Evaluation and Research
• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal ContraceptivesCenter for Drug Evaluation and Research
• Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessGuidance Document · Center for Drug Evaluation and Research
• Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Nonclinical Studies for the Safety Evaluation of Pharmaceutical ExcipientsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 315100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk ConsiderationsGuidance Document · Human Foods Program
• CPG Sec 560400 Imported Milk and Cream - Federal Import Milk ActCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555425 Foods, Adulteration Involving hard or Sharp Foreign ObjectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525225 - Whole Cassia or Whole Cinnamon, Ground Cinnamon - Adulteration by Insect and Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Evaluating the Risks of Drug Exposure in Human PregnanciesGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective SupplierCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Providing Regulatory Submissions in Electronic Format — Content of LabelingGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Templates for Reporting Toxicology DataGuidance Document · Human Foods Program
• Guidance for Industry: Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact ArticlesGuidance Document · Human Foods Program
• CPG Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic ProductsGuidance Document · Office of Regulatory Affairs
• Guidance for Industry: Pre-Petition Consultations for Food Additives and Color AdditivesGuidance Document · Human Foods Program
• E2E Pharmacovigilance PlanningGuidance Document · Center for Drug Evaluation and Research
• Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA ProductsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Dietary Supplement Labeling GuideGuidance Document · Human Foods Program
• Premarketing Risk Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development and Use of Risk Minimization Action Plans: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 300500 *Reprocessing of Single Use* DevicesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• E2B(M) Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601Guidance Document · Center for Drug Evaluation and Research
• Pharmacogenomic Data Submissions: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 398.700 Reloaders of X-ray Tube Housing Assemblies; Applicability of Medical Device Establishment Registration, Device Listing and Biennial InspectionGuidance Document · Office of Regulatory Affairs
• CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray EquipmentGuidance Document · Office of Regulatory Affairs
• CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b)Compliance Policy Guide (CPG) · Office of Regulatory Affairs Center for Devices and Radiological Health
• CPG Sec. 396.300 Defective Suntanning Booths and BedGuidance Document · Office of Regulatory Affairs
• CPG Sec 310210 Blood Pressure Measurement Devices (Sphygmomanometers) - AccuracyCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFAGuidance Document · Center for Veterinary Medicine
• CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)Guidance Document · Center for Veterinary Medicine
• Gingivitis: Development and Evaluation of Drugs for Treatment or PreventionGuidance Document · Center for Drug Evaluation and Research
• Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy AcidsGuidance Document · Office of the Commissioner,Office of the Chief Scientist
• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• M4: The CTD -- General Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• M4: The CTD -- Efficacy Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and OmnivoresGuidance Document · Center for Veterinary Medicine
• CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records RetentionCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and LabelingGuidance Document · Center for Drug Evaluation and Research
• Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction PurposesGuidance Document · Human Foods Program
• FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)Special Controls Document · Center for Devices and Radiological Health
• The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• Independent Consultants for Biotechnology Clinical Trial Protocols: Guidance for IndustryGuidance Document · Office of the Commissioner
• Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety AssessmentsGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical StudiesGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 2: Clinical IndicationsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 690.300 Canned Pet Food (Withdrawn 4/30/2019)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• M4: The CTD -- Quality Questions and Answers /Location IssuesGuidance Document · Center for Drug Evaluation and Research
• Q1E Evaluation of Stability DataGuidance Document · Center for Drug Evaluation and Research
• Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version)Special Controls Document · Center for Devices and Radiological Health
• Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Guidance for Industry and FDA Staff: Spinal System 510(k)sGuidance Document · Center for Devices and Radiological Health
• CVM GFI #144 (VICH GL27) Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial ResistanceGuidance Document · Center for Veterinary Medicine
• Redbook 2000: VII Glossary, Acronyms and DefinitionsGuidance Document · Human Foods Program
• Changes to an Approved NDA or ANDA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 490100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market ApprovalCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Potassium Iodide Tablets - Shelf Life ExtensionGuidance Document · Center for Drug Evaluation and Research
• Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First EditionGuidance Document · Human Foods Program
• Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] SubmissionsGuidance Document · Center for Devices and Radiological Health
• IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Q1A(R2) Stability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• Redbook 2000: IV.B.2 Guidelines for Reporting the Results of Toxicity StudiesGuidance Document · Human Foods Program
• Redbook 2000: IV.C.5.b. One-Year Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.4.b. Subchronic Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.4.a. Subchronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.3.b. Short-Term Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.3.a. Short-Term Toxicity Studies with RodentsGuidance Document · Human Foods Program
• Redbook 2000: IV.C.1.b. In vitro Mammalian Chromosomal Aberration TestGuidance Document · Human Foods Program
• Redbook 2000: IV.B.1. General Guidelines for Designing and Conducting Toxicity StudiesGuidance Document · Human Foods Program
• Redbook 2000: IV. A. Introduction to Guidelines for Toxicity StudiesGuidance Document · Human Foods Program
• Small Entity Compliance Guide: Label Warning Statements for Iron-Containing Supplements and DrugsSmall Entity Compliance Guide · Human Foods Program
• E2D Postapproval Safety Data Management: Definitions and Standards for Expedited ReportingGuidance Document · Center for Drug Evaluation and Research